This is a fully remote position
PURPOSE AND SCOPE:
Develops regulatory strategies for assigned products/product lines. Prepares regulatory submissions required to market new or modified medical devices in the domestic and international clinical markets. Develops and maintains procedures and systems designed to ensure the product development process addresses all regulatory requirements as well as the objectives of the business.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
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.
10 – 15% domestic and international travel as required.
EDUCATION:
Bachelor’s Degree required; Advanced Degree preferred
EXPERIENCE AND REQUIRED 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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