dismissed EB-1C Case: Medical Devices

U.S. Citizenship 
and Immigration 
Services 
In Re: 7790589 
Appeal of Nebraska Service Center Decision 
Non-Precedent Decision of the 
Administrative Appeals Office 
Date: APR. 17, 2020 
Form 1-140, Petition for Multinational Managers or Executives 
The Petitioner, a manufacturer and seller of medical devices, seeks to permanently employ the 
Beneficiary as its chief operating officer (COO) in the United States under the first preference 
immigrant classification for multinational executives or managers. Immigration and Nationality Act 
(the Act) section 203(b)(l)(C), 8 U.S.C. § 1153(b)(l)(C). 
The Director of the Nebraska Service Center denied the petition concluding that the Petitioner did not 
establish that the Beneficiary would be employed in a managerial or executive capacity in the United 
States. The Petitioner later filed a motion to reopen and a motion to reconsider. The Director granted 
the motion to reopen, but affirmed her denial of the petition. The Petitioner later filed an appeal that 
we rejected as untimely. However, we then issued a service motion reopening the appeal. 
On appeal, the Petitioner asserts the Director did not properly consider whether the Beneficiary would 
qualify as a function manager. In the alternative, the Petitioner further contends that the Beneficiary 
would qualify as a personnel manager based on her supervision of subordinate managers and 
professionals, including several employees working abroad for the foreign employer. 
In these proceedings , it is the Petitioner's burden to establish eligibility for the requested benefit. 
Section 291 of the Act, 8 U.S.C. § 1361. Upon de nova review, we will dismiss the appeal. 
I. LEGAL FRAMEWORK 
An immigrant visa is available to a beneficiary who, in the three years preceding the filing of the 
petition, has been employed outside the United States for at least one year in a managerial or executive 
capacity, and seeks to enter the United States in order to continue to render managerial or executive 
services to the same employer or to its subsidiary or affiliate. Section 203(b)(l)(C) of the Act. 
The Form 1-140, Immigrant Petition for Alien Worker, must include a statement from an authorized 
official of the petitioning United States employer which demonstrates that the beneficiary has been 
employed abroad in a managerial or executive capacity for at least one year in the three years preceding 
the filing of the petition, that the beneficiary is coming to work in the United States for the same 
employer or a subsidiary or affiliate of the foreign employer, and that the prospective U.S. employer 
has been doing business for at least one year. See 8 C.F.R. § 204.5(j)(3). 
II. U.S. EMPLOYMENT IN A MANAGERIAL CAPACITY 
The sole issue we will address is whether the Petitioner established that the Beneficiary would act in 
a managerial capacity in the United States. The Petitioner does not claim that the Beneficiary would 
be employed in an executive capacity. Therefore, we restrict our analysis to whether the Beneficiary 
would be employed in a managerial capacity. 
"Managerial capacity" means an assignment within an organization in which the employee primarily 
manages the organization, or a department, subdivision, function, or component of the organization; 
supervises and controls the work of other supervisory, professional, or managerial employees, or 
manages an essential function within the organization, or a department or subdivision of the 
organization; has authority over personnel actions or functions at a senior level within the 
organizational hierarchy or with respect to the function managed; and exercises discretion over the 
day-to-day operations of the activity or function for which the employee has authority. Section 
10l(a)(44)(A) of the Act, 8 U.S.C. § l 10l(a)(44)(A). 
When examining the managerial capacity of a given beneficiary, we will review the petitioner's 
description of the job duties. The petitioner's description of the job duties must clearly describe the 
duties to be performed by the beneficiary and indicate whether such duties are in a managerial 
capacity. 8 C.F.R. § 204.5(j)( 5). Beyond the required description of the job duties, we examine the 
company's organizational structure, the duties of a beneficiary's subordinate employees, the presence 
of other employees to relieve a beneficiary from performing operational duties, the nature of the 
business, and any other factors that will contribute to understanding a beneficiary's actual duties and 
role in a business. 
Accordingly, we will discuss evidence regarding the Beneficiary's job duties along with evidence of 
the nature of the Petitioner's business, its staffing levels, and its organizational structure. 
A. Duties 
Based on the statutory definition of managerial capacity, the Petitioner must first show that the 
Beneficiary will perform certain high-level responsibilities. Champion World, Inc. v. INS, 940 F.2d 
1533 (9th Cir. 1991) (unpublished table decision). The Petitioner must also prove that the Beneficiary 
will be primarily engaged in managerial duties, as opposed to ordinary operational activities alongside 
the Petitioner's other employees. See Family Inc. v. USCIS, 469 F.3d 1313, 1316 (9th Cir. 2006); 
Champion World, 940 F.2d 1533. 
The Petitioner indicated that it is "primarily engaged in manufacturing. J I devices in China" 
and establishing global marketing and distribution networks for these The Petitioner 
indicated that it "developed its patente technolo which is a 
proprietary I I process that modifies.__ ___ _. into '-------.,--~-----~ forming 
I I polymers." The Petitioner stated that as COO the Beneficiary "formulates corporate 
administrative policies, personnel policies, and company directives" and "represents the company in 
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negotiations and in [the] execution of major business contracts and agreements." It further explained 
that the Beneficiary was tasked with the "implementation of the ISO 13485 quality management 
system" and its "appointed representative for quality system matters," including their implementation 
in all departments and solving any product development and logistics issues. The Petitioner also 
provided the following duty description for the Beneficiary throughout the record: 
• Frequently confers with CEO to compare notes and discusses issues pertaining to 
business, financial, legal and marketing operations. Works with the president in 
sales marketing to develop, revise and perfect company international marketing 
plans and strategies. Leads the RA team for product submissions, including CE 
and FDA license renewals and periodic updates and registrations to regulatory 
agencies. Responsible for organizing regulatory information and tracking and 
controlling submissions, reviewing and advising on labeling for compliance with 
regulatory filings worldwide, and researching regulatory issues. (25%) 
• Directs and advises department managers to deal with specific management 
problems such as employee hiring and promotion, revision of marketing plans and 
sales goal adjustment. Coordinates inter-department activities and directs lower 
managers to resolve problems, and she plans procedures, and establishes and 
delegates among the managers. Develops overall corporate operational and 
managerial policies and decisions with respect to the international marketing of 
products, including issuing directives or memos concerning marketing budgets, 
issues, or plans. Adjusts and improves corporate marketing research and 
development policies and plans in collaboration with other managerial personnel. 
(25%) 
• Directs the department managers through various meetings, memos, notices and 
directives in the development and the expansion of marketing channels and 
distributorships. Improves product quality and competitiveness and coordinates 
technical activities with other affiliates. Determines areas of potential cost 
reduction, program improvement, or policy change. (15%) 
• Exercises personnel authority over department managers and employees. 
Determines employment benefits, commissions, awards, and bonuses based on job 
performance and sales fulfillment goals. Conducts human resource activities, 
including approval of human resources plans and activities, training programs, and 
selection of managers and staffers pertaining to international marketing activities. 
(10%) 
• Reviews and approves major contracts and agreements with suppliers, distributors, 
investors, government agencies, and other organizational entities. Reviews reports 
submitted by lower managers recommending approval or changes and ensures 
international marketing department stays within budgetary limits. (10%) 
• Assigns or delegates responsibilities to subordinate managers and directs managers 
in the coordination of international and domestic marketing transactions. Reviews 
and approves suggestions, reports and plans from department managers regarding 
company promotion, marketing and distribution of hemostat products. (10%) 
• Periodically evaluates and analyzes sales and marketing operations and determines 
its financial budget, positions, and areas of cost reduction and program 
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improvement. Reviews financial statements and sales reports to ensure 
international financial objectives are achieved. (5%) 
The Petitioner submitted a U.S. duty description for the Beneficiary that does not sufficiently 
demonstrate she would devote a majority of her time to qualifying managerial level duties. The 
provided duty description includes several generic duties that could apply to any manager within any 
company and industry and they add little insight into her actual day-to-day tasks. For instance, the 
Petitioner provided few details and little supporting documentation to substantiate the financial or 
marketing operations the Beneficiary directed, the international marketing plans and strategies she 
developed, management problems she dealt with, or sales goals she adjusted. Likewise, the Petitioner 
did not provide sufficient specifics or documentation to corroborate the problems the Beneficiary 
resolved through lower managers, plans and procedures she delegated to managers and departments, 
operational or managerial policies she developed, international marketing budgets she managed, 
directives or memos she issued, or adjustments or improvements she made to marketing research and 
policies. 
The Petitioner also did not sufficiently describe or document the marketing channels and 
distributorships the Beneficiary expanded, improvement she made to product quality, areas of cost 
reduction or program improvement she determined, training programs she approved, or promotion 
activities she directed. This lack of detail and documentation is particularly notable since the Petitioner 
asserts that the Beneficiary has been acting in her asserted role as far back as 2009. 1 In addition, the 
Beneficiary's duty description emphasizes her delegation of duties to several subordinate managers, 
both in the United States and abroad, including implementing sales and marketing plans and quality 
control procedures, as well as exercising personnel authority over her claimed managers. However, 
there is little supporting evidence of the Beneficiary delegating duties and general goals and policies 
to her claimed managerial subordinates or of her exercising personnel authority over them. Specifics 
are clearly an important indication of whether a beneficiary's duties are primarily managerial in nature, 
otherwise meeting the definitions would simply be a matter ofreiterating the regulations. Fedin Bros. 
Co., Ltd. v. Sava, 724 F. Supp. 1103, 1108 (E.D.N.Y. 1989), ajf'd, 905 F.2d 41 (2d. Cir. 1990). 
In fact, to the extent that the Petitioner provided detail and documentation regarding the Beneficiary's 
activities, this evidence is reflective of her likely performance of non-qualifying operational tasks 
rather than managerial authority. For instance, the Beneficiary's duty description refers to her 
handling "CE and FDA license renewals" and technical file updates and maintenance, tracking and 
controlling of regulatory submissions, reviewing labels for compliance with regulatory filings, 
reviewing product changes for impact on regulatory filings, and researching regulatory issues. In 
addition, the Petitioner stated that the Beneficiary handles "the complicated process of product 
submissions, certificate renewals, technical file updates, and registrations to regulatory agencies." 
However, there is little evidence of the Beneficiary delegating these operational functions to 
subordinates. Similarly, the Petitioner provided evidence of the Beneficiary regularly transferring 
funds to its foreign affiliate in China to maintain its operations and offering advice on test requirements 
to colleagues in June 201 7. In contrast, there is little evidence reflecting to substantiate the 
Beneficiary's claimed elevated position within the organization and her asserted oversight of a 
1 The petition was filed on April 25, 2017. 
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president in the United States and several other managers abroad operating a manufacturing facility in 
China. 
Whether the Beneficiary is a managerial employee turns on whether the Petitioner has sustained its 
burden of proving that their duties are "primarily" managerial. See sections 101(a)(44)(A) of the Act. 
Here, the Petitioner does not sufficiently document what proportion of the Beneficiary's duties would 
be managerial functions and what proportion would be non-qualifying operational tasks. Although 
the Petitioner lists managerial tasks within the Beneficiary's duty description and asserts she devotes 
75% of her time to them, it does not credibly substantiate this assertion with evidence that she primarily 
delegates her stated non-qualifying operational tasks to her subordinates. For this reason, we cannot 
determine whether the Beneficiary is primarily performing the duties of a manager. See IKEA US, 
Inc. v. US. Dept. of Justice, 48 F. Supp. 2d 22, 24 (D.D.C. 1999). 
Even though the Beneficiary holds a senior position within the organization, the fact that she will 
manage or direct a portion of the business does not necessarily establish eligibility for classification 
as a multinational manager within the meaning of section 101(a)(44)(A) of the Act. The Beneficiary 
may exercise discretion over the Petitioner's day-to-day operations and possess the requisite level of 
authority with respect to discretionary decision-making; however, the position description alone is 
insufficient to establish that her actual duties would be primarily managerial in nature. 
B. Staffing and Function Manager 
If staffing levels are used as a factor in determining whether an individual is acting in a managerial 
capacity, we take into account the reasonable needs of the organization, in light of its overall purpose 
and stage of development. See section 101 (a)( 44 )( C) of the Act. 
The Petitioner asserted that the Beneficiary manages subordinate managers and professionals both in 
the United States and abroad; and further contends in the alternative that she would also qualify as a 
function manager. The statutory definition of "managerial capacity" allows for both "personnel 
managers" and "function managers." See section 10l(a)(44)(A) of the Act. Personnel managers are 
required to primarily supervise and control the work of other supervisory, professional, or managerial 
employees. Contrary to the common understanding of the word "manager," the statute plainly states 
that a "first line supervisor is not considered to be acting in a managerial capacity merely by virtue of 
the supervisor's supervisory duties unless the employees supervised are professional." Id. If a 
beneficiary directly supervises other employees, the beneficiary must also have the authority to hire 
and fire those employees, or recommend those actions, and take other personnel actions. 8 C.F.R. § 
204.5(j)(2). 
The Petitioner submitted a U.S. organizational chart reflecting that the Beneficiary reported to a CEO 
and indicating she oversaw a president (sales marketing). The president was shown to supervise 
several departments, including business development, sales marketing and global distribution, 
administration/human resources/finance, regulatory affairs/compliance, and business operations 
(China). The business development department was not shown to include any employees, while the 
chart reflected that the sales marketing and global distribution department was made up of two sales 
consultants, a customer support/logistics employee, and two regional managers listed as "to be hired." 
In addition, the chart indicated that the administration/human resources/finance department included 
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an accountant, as well as a R&D director and a production manager both shown as "to be hired." The 
chart also showed that the regulatory affairs/compliance department included an assistant manager. 
Furthermore, the Petitioner also asserted that the Beneficiary managed a foreign subsidiary's 
operations in China consisting of two R&D project managers, a sales marketing customer support 
manager, an administration/human resources/finance manager, a "regulatory affairs FDA5 l OK project 
consultant," and a quality assurance employee. The chart further indicated that the 
administration/human resources/finance manager supervised an accountant and an 
administration/logistics coordinator. 
The Petitioner also explained that the Beneficiary supervised a manufacturing site in China and 
provided another organizational chart headed by a foreign general manager. This manufacturing site 
chart reflected that the general manager oversaw two vice general managers and a quality control 
manager. One vice general manager was shown to supervise a production manager overseeing a 
production workshop supervisor, a machinery equipment supervisor, and a "R&D team" with several 
employees. The chart also indicated that the other vice general manager oversaw a 
purchasing/logistics manager supervising the "raw material warehouse" and an "admin/finance 
manager" responsible for an "admin/HR assistant manager" and a "regulatory affairs CFDA 
registrations supervisor." Lastly, the quality control manager was shown to oversee a quality 
assurance assistant manager and an associate, both supervising "testing, validation, [ and] document 
control." 
In total, the Petitioner emphasizes that the Beneficiary oversees an extensive organizational structure 
both in the United States and in China with subordinate managers and professionals, including over 
30 employees abroad. The Petitioner emphasizes foreign operations managed by the Beneficiary and 
contends that the Director improperly concluded that these could not be considered in determining 
whether she qualifies as a manager in the United States. First, we acknowledge that foreign 
subordinates and operations can be considered as a part of qualifying manager's U.S. position. 
However, a petitioner must properly substantiate that a beneficiary exercises personnel authority over 
subordinate manager and professionals abroad in order to demonstrate their eligibility as a personnel 
manager of foreign employees. Here, the Petitioner submits little supporting documentation to 
establish the Beneficiary's personnel authority over several claimed managers and professionals 
abroad. 
For instance, the Petitioner provided a "quality manual" issued by the U.S. CEO in April 2018 stating 
that the Beneficiary was being appointed as "the company's management representative" and that she 
would tasked with "ensuring that the processes required for the quality management are documented," 
reporting on the effectiveness of "quality management system and any need for improvement," and 
"ensuring the promotion of awareness of applicable regulatory requirements." First, it is questionable 
that this appointment document was dated in April 2018 and signed in June 2018 when the Petitioner 
contends that the Beneficiary has been acting in her role overseeing all of the foreign employer's 
operations for several years. The Petitioner must resolve inconsistencies and discrepancies in the 
record with independent, objective evidence pointing to where the truth lies. Matter of Ho, 19 I&N 
Dec. 582, 591-92 (BIA 1988). 
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The Petitioner also provided a few emails reflecting the Beneficiary's apparent involvement in an audit 
of its claimed manufacturing location in China. However, none of this documentation reflects that the 
Beneficiary has personnel authority over the foreign employer's asserted manufacturing facility or 
other managers based abroad. Beyond this, the Petitioner provides only one email dated prior to the 
petition indicating the Beneficiary's interaction with employees abroad. The Petitioner's supporting 
documentation does not sufficiently substantiate that the Beneficiary acts at the head of an extensive 
organization abroad with over nine managers and more than thirty operational level employees as 
claimed. The Beneficiary's duty description indicates that she "frequently directs and advises 
department managers," "continually" coordinates with them, and conducts human resources activities 
with respect to them. However, there is questionably little supporting documentation of this asserted 
frequent and continual communication and direction, or of her exercising personnel authority over 
foreign subordinates. In sum, there is insufficient evidence to establish that the Beneficiary acts as a 
personnel manager over foreign employees as claimed. 
In addition, the Petitioner provides little supporting evidence to demonstrate the Beneficiary's 
personnel authority over subordinate managers and professionals in the United States. For instance, 
the submitted organizational chart indicated that the Beneficiary supervises a president ( sales 
marketing); however, it provided only one document to support her oversight of this claimed 
subordinate manager, a report emailed to both her and the company's CEO, the apparent founder of 
the company. The president's report indicates that he acts independently and there is little elsewhere 
in the record to document the Beneficiary exercising authority over him or delegating duties. 
Likewise, there is no supporting evidence to substantiate that the Beneficiary supervises or delegates 
duties to the other claimed members of its organizational structure in the United States. 
For example, a state quarterly wage report from the first quarter of 2017 indicated that the Petitioner 
employed the Beneficiary, the CEO (the Beneficiary's supervisor), the president (sales marketing), 
and the asserted accounting employee and regulatory affairs employee. However, there is no evidence 
of the Beneficiary acting as a personnel manager with respect to any of these employees. The 
Petitioner's staffing leaves question as to how the Beneficiary was directing "international marketing 
activities," as there appear to be few employees to perform the operational aspects of this function. In 
fact, the Petitioner indicated that it requires $5 to $10 million investment in the company and noted 
that it plans to hire two to three regional marketing managers and other sale representatives in the 
future. These statements and the supporting evidence leave substantial uncertainty as to whether the 
Beneficiary has a claimed international marketing organization with subordinate managers and 
professionals to coordinate as asserted on the record. The Petitioner does not resolve this uncertainty 
with objective documentary evidence reflecting her personnel authority over subordinate managers 
and professionals. For the foregoing reasons, the Petitioner has not established that the Beneficiary 
would act as a personnel manager in the United States. 
Furthermore, the Petitioner asserts that the Beneficiary qualifies as a function manager. The term 
"function manager" applies generally when a beneficiary does not supervise or control the work of a 
subordinate staff but instead is primarily responsible for managing an "essential function" within the 
organization. See section 101(a)(44)(A)(ii) of the Act. If a petitioner claims that a beneficiary will 
manage an essential function, it must clearly describe the duties to be performed in managing the 
essential function. In addition, the petitioner must demonstrate that "(1) the function is a clearly 
defined activity; (2) the function is 'essential,' i.e., core to the organization; (3) the beneficiary will 
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primarily manage, as opposed to perform, the function; (4) the beneficiary will act at a senior level 
within the organizational hierarchy or with respect to the function managed; and ( 5) the beneficiary 
will exercise discretion over the function's day-to-day operations." Matter of G- Inc., Adopted 
Decision 2017-05 (AAO Nov. 8, 2017). 
In asserting the Beneficiary as a function manager, the Petitioner states that she "formulates corporate 
administrative policies, personnel policies, and company directives" and that she manages "all legal 
and regulatory matters." It indicated that this includes managing intellectual property, research and 
development of new products, and distributing this information "in compliance with stringent and 
varying governmental regulations on medical technologies." It also stated that the Beneficiary was 
tasked with overseeing "the complicated process of product submissions, certificate renewals, 
technical file updates, and registrations to regulatory agencies." As an example, the Petitioner noted 
that the Beneficiarl "is overseeing the process to apply for approval of the I I Product 
andl with the [FDA]." The Petitioner indicates that these duties represent an essential 
function of its business. 
Although we acknowledge that the function of regulatory compliance appears essential given the 
nature of the Petitioner's business, it has not provided sufficient evidence to establish that the 
Beneficiary is primarily engaged in managing this function rather than performing it. For instance, 
the Petitioner indicates that the Beneficiary formulates administrative and personnel policies and 
company directives, yet there is little detail and supporting documentation to corroborate her 
performance of these claimed managerial functions. The Petitioner contends that the Beneficiary 
"oversees" the product submission process with regulatory agencies, but there is no supporting 
documentation reflecting her directing these activities and delegating non-qualifying operational tasks 
to subordinates. 
For example, the Petitioner compares the Beneficiary's role to the facts of Matter of Z-A-, Inc. where 
a vice president of an international company was found to qualify as a function manager despite there 
being only two employees on that U.S. petitioner's payroll. In that matter, the petitioner provided 
substantial documentary evidence indicating that the beneficiary was supported by eight employees 
abroad who assisted him in his day-to-day activities. However, here, the Petitioner does not submit 
documentary evidence reflecting the Beneficiary management of her function, her delegation of tasks 
to subordinates, or her being relieved from performing the non-qualifying duties within her function. 
Without this evidence, we cannot conclude that the Beneficiary is more likely than not being relieved 
from the non-qualifying operational aspects of her claimed function, which are discussed in her duties, 
such as the license renewals, technical file updates and maintenance, tracking and controlling of 
regulatory submissions, reviewing labels for compliance with regulatory filings, reviewing product 
changes for impact on regulatory filings, and researching regulatory issues. In other words, the 
Petitioner has not sufficiently established that the Beneficiary is primarily managing a function rather 
than performing it. As such, the Petitioner did not submit sufficient evidence to demonstrate that the 
Beneficiary would act as a function manager. 
For the foregoing reasons, the Petitioner has not established that the Beneficiary would qualify as a 
manager in the United States. 
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ORDER: The appeal is dismissed. 
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