Available Openings 1
PURPOSE AND SCOPE:
The incumbent will manage the regulatory process, both domestic and international markets, for NxStage Medical, Inc. products and provide regulatory input into key quality system processes, such as design controls, change control, labeling and advertising and others. The incumbent may supervise regulatory staff.
PRINCIPAL DUTIES AND RESPONSIBILITIES
- Develop regulatory strategies and plans for NxStage Medical, Inc. products.
- Prepare and submit US regulatory submissions including 510(k)’s, IDE’s, etc.
- Prepare and submit international regulatory submissions, as international market develops. This includes but is not limited to Canada, Europe (CE Mark), Mexico, Asia, etc.
- Monitor regulations, guidance and standards and communicate applicable requirements to affected departments of NxStage.
- Determine impact of product and system changes on regulatory status for both US and OUS distributions.
- Prepare documentation to support no-filing decisions for US & International Markets.
- Participate on cross-functional developmental teams including project planning and design review activities.
- Participate in compliance related activities, including Quality System Audits, labeling reviews, and verification/validation reviews.
- Maintain corporate regulatory files.
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.
- Travel requirements – Occasional Meetings
- Bachelor’s Degree required; Advanced Degree preferred
EXPERIENCE AND REQUIRED SKILLS:
- 4+ years experience in Regulatory Affairs in the medical device industry
- Expertise in working within Medical Device Regulations including Quality System Regulation 21 CFR Part 820, ISO 13485, EU MDD/MDR, Canadian Regulations
- Experience in product development of medical devices a plus
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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