Fresenius Medical Care
Available Openings 1
Position Specific Information
This position can be located anywhere in the US.
PURPOSE AND SCOPE:
The Associate General Counsel FDA Regulatory supports the North American medical products business. Work closely with FDA regulations to assist the company in obtaining FDA clearance and approval to market products.
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, clinical studies, medical device reporting, corrections and removals, product approvals, inspections and FDAs quality system regulations.
- Assists the management and business clients in meeting commercial goals with appropriate legal and business oversight.
- 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.
- Monitors the external regulatory and enforcement environment to identify risks to the Company and its customer relationships, day-to-day counseling and training of Companys functional groups.
- Updates management on regulatory developments and communicate new developments to the affected business clients.
- 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.
- Provides litigation support (directly or in conjunction with outside counsel) related to FDA regulatory 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.
- Advises and counsels the Company on marketing and promotional matters.
- Assists the Company in obtaining the FDA clearance and approval to market products.
- Works with RA/QA teams on any updates to the Medical Device Reporting database.
- Assists in complying with FDA post-market requirements.
- 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.
- Manages outside FDA regulatory counsel.
- 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.
May be responsible for the direct supervision of various levels of legal staff.
Juris Doctor Degree from an accredited college or university required.
EXPERIENCE AND REQUIRED SKILLS:
- 10+ years related experience.
- 5+ years experience as a Manager; or 5+ years experience in a senior managerial role.
- Regulations, Investigational Device Exemptions, Investigational Review Boards, Marketing/Advertising/Promotion Regulations.
- Additional expertise in FDA pharmaceutical regulation is highly desirable, but not required.
- Licensed to practice law.
- 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.