PURPOSE AND SCOPE:
The Assistant General Counsel II Regulatory Care Enablement reports to the Global Legal Head of Healthcare Law, Quality and Regulatory Affairs - Medical Technology (Care Enablement), supports the global medical technology business, and acts as a legal business partner to executive leadership, with particular emphasis in the North America region, in understanding and complying with applicable legal and regulatory requirements for obtaining approval/clearance to market medical technologies, including medical products, equipment, and solutions for dialysis and critical care treatments, and in manufacturing and quality, safety, and marketing and distributing products to ensure regulatory compliance and patient and consumer access.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Supports the North American medical technology business, principally with respect to the application of and compliance with US Food, Drug and Cosmetic Act and Food and Drug Administration regulations and guidances for medical technologies and pharmaceuticals, including those relating to PMA, 510(k), NDA and ANDA submissions; pre- and post-approval/clearance; promotion and advertising; quality and safety data exchange agreements; medical device reporting and pharmacovigilance; recalls, corrections and removals; inspections; and FDA’s quality system regulations.
- Acts as a strategic legal partner to executive leadership and medical technology business leaders in North America by providing practical and business-oriented guidance on issues of FDA law, regulation and policy; government policy and enforcement; and in the compliance area.
- Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with FDA and foreign regulatory authorities’ and the Company’s standards.
- Provide legal and strategic advice related to clinical decision software and digital health technologies used in medical product development and regulated activities, and maintain awareness and understanding of evolving regulatory frameworks, proposed legislation and rulemaking, and new policies or guidance documents which may significantly impact the Company’s business.
- Provides proactive operational legal advice on sales and marketing materials and communications for both internal and external audiences related to the Company’s technologies.
- Partners with the Regulatory Affairs and Quality Assurance (RA/QA) teams in complying with FDA post-market requirements.
- Counsels the RA/QA teams in developing policies, procedures, product manuals, legal guidance documents, tools and training materials.
- Monitors the external regulatory and enforcement environment to identify risks to the Company and its customer relationships and updates executive leadership on such developments.
- Selects and supervises outside counsel, when such counsel is required, and efficiently manages legal expenses.
- Works with other team members to develop and maintain subject matter expertise in laws, regulations, and policies governing medical technologies in Canada, Mexico, EU, and other global markets, especially including evolving regulatory frameworks that may impact the Company’s medical technologies business.
- Provides regulatory support (directly or in conjunction with in-house and outside litigation counsel) in litigations involving FDCA or Company’s medical technology business.
- Supports the Company, as requested, in interactions with regulatory authorities in North America or in interactions with other Fresenius Medical Care 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.
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.
- Occasional travel may be required.
- Juris Doctor Degree from an ABA-accredited college or university required.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum of 5 years’ related experience as a practicing attorney.
- Experience in healthcare regulatory compliance.
- 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 executive leadership 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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