Regulatory Affairs Lead
1 week ago
HuMannity Medtec, a pioneer in life-enhancing medical technologies, seeks an experienced Principal Regulatory Affairs Specialist to join their team of engineers, scientists, and medical device experts. The ideal candidate will have 8+ years of experience in the medical device industry, with a focus on Class III products.
The successful applicant will be responsible for developing and implementing regulatory strategies to obtain timely approvals for early feasibility studies. This involves creating regulatory submissions, providing critical input on cross-functional project teams, and ensuring compliance with ISO 14971 and cybersecurity requirements.
Key responsibilities include:
- Leading risk management activities, including FMEAs, hazard analysis, plans, reports, and trace matrices.
- Participating in development teams to ensure regulatory requirements are incorporated into the product development process.
- Creating and submitting regulatory submissions based on the regulatory strategy.
- Reviewing and approving engineering change order documents.
- Reviewing promotional material and labeling for regulatory compliance.
- Assisting with negotiations and interactions with regulatory authorities.
We offer a competitive salary range of $120,000 - $160,000 per year, along with a 9/80 schedule and every other Friday off. This allows for 26 long weekends per year, enabling our team members to achieve a better work-life balance.
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Santa Clarita, California, United States huMannity Medtec Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at huMannity Medtec. The ideal candidate will have a strong background in medical device development and a proven track record of ensuring regulatory compliance.Job SummaryThe Principal Regulatory Affairs Specialist will be responsible for participating on product...
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