The Associate General Counsel FDA Regulatory (a) supports the North American medical products business, working closely with FDA regulations to assist the company in obtaining FDA clearance and approval to market products and in marketing and selling such products in compliance with these regulations; and (b) oversees attorneys who identify and manage legal issues related to North American and global clinical research matters.

This individual will be part of FMCNA’s inclusive and collegial Law Department, which is comprised of nearly 60 lawyers and additional professionals working on cutting-edge legal issues across seven practice groups, including Corporate, Integrated Care, Labor and Employment, Litigation, Payor Relations, Regulatory, and Specialty Services, in support of FMCNA’s wide range of businesses.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Supports the North American medical products business primarily on the US Food, Drug and Cosmetic Act, medical device regulations and policies, including those relating to recalls, promotion and advertising, medical device reporting, corrections and removals, product approvals, inspections and FDA’s quality system regulations.
Acts as a strategic legal partner to our senior managers and the medical products business in North America in substantive legal areas on issues of FDA law, regulation and policy, government policy and enforcement, and in the compliance area.
Provides advice and counsel on various sales and marketing as well as other materials for dissemination relating to the Company and its potential products, as well as respond to requests from the RA/QA teams for reviewing product labeling and liability questions.
Partners with clients’ Regulatory Affairs/Quality Assurance teams to assist and counsel in developing policies, procedures, product manuals, legal guidance documents, tools and training materials.
Works with RA/QA teams on any updates to the Medical Device Reporting database.
Assists in complying with FDA post-market requirements.
Monitors the external regulatory and enforcement environment to identify risks to the Company and its customer relationships, day-to-day counseling and training of Company’s functional groups.
Updates management on regulatory developments and communicate new developments to the affected business clients.
Assists the management and business clients in the medical products and clinical research businesses in meeting commercial goals with appropriate legal and business oversight.
Oversees attorneys who provide counsel and guidance to the Company’s research and development groups, including but not limited to Frenova Renal Research, the Renal Research Institute, the Renal Therapies Group, and the North American and global medical offices, with respect to all applicable business conduct, regulatory, and health and safety laws, statutes, rules and regulations, and guidelines, including but not limited to regulations and guidance governing the conduct of clinical research and the protections of human subjects.
Provides litigation support (directly or in conjunction with outside counsel) related to FDA regulatory and clinical research matters.
Supports the Company, as requested, in interactions with regulatory authorities in North America or in interactions with other Fresenius subsidiaries internationally.
Provides legal support for compliance investigations involving issues with the FDA.
Builds and maintains relationships with key healthcare industry regulators.
Performs other Duties as assigned.

Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISION:

May be responsible for the direct supervision of various levels of legal staff.

EDUCATION:

Juris Doctor Degree from an ABA-accredited college or university required.

EXPERIENCE AND REQUIRED SKILLS:

10+ years’ related experience advising on topics such as FDA Medical Device and Pharmaceutical regulations; Marketing/Advertising Promotion regulations; familiarity with Clinical Research regulations, including clinical research contracting..
5+ years’ experience as a Manager; or 5+ years’ experience in a senior managerial role.
Licensed to practice law in at least one U.S. state, U.S. territory, or Washington, D.C..
Strong management skills with the ability to lead cohesive and productive teams.
Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
Excellent oral and written communication skills.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.

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