Principal Regulatory Affairs Specialist

Company: Fresenius Kidney Care
Location: Lawrence
Posted on: September 16, 2023

Job Description:

Principal Regulatory Affairs Specialist page is loaded Principal Regulatory Affairs Specialist Apply locations Lawrence, MA, USA time type Full time posted on Posted 2 Days Ago job requisition id R0098780 Position Summary: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.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.
• Communicate directly with senior management, economic operators, and regulatory agencies on all regulatory issues.
• 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.Education & Qualifications:
  • B.S. in technical discipline preferred or equivalent experience
  • 8+ years' experience in domestic and international Regulatory Affairs in the medical device industry
  • Experience interacting with FDA regarding regulatory matters
  • 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 plusEO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender IdentityFresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws. 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. About Us Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the #1 Top Workplace in the area. Join our Talent Network! Let's stay connected! Joining our talent network allows us to send you new job opportunities!

Keywords: Fresenius Kidney Care, Lawrence , Principal Regulatory Affairs Specialist, Other , Lawrence, Massachusetts