Principal Regulatory Affairs Specialist-Remote Based

Company: Biolink360
Location: Santa Barbara
Posted on: June 1, 2025

Job Description:

Principal Regulatory Affairs Specialist - Remote BasedOur client is an industry-leading Regulatory and Quality consulting company experiencing consistent growth, especially in Regulatory Affairs hiring. They collaborate with startups to Fortune 500 device companies, offering diverse client projects.These are full-time, permanent, remote-based positions. You will be fully integrated with client teams, working collaboratively to meet project deliverables.Company highlights include:

• Women-owned business, 14 years established, with owners actively involved with clients and employees.
• Access to experts, opportunities to work on new technologies, projects, and clients.
• High employee satisfaction, with over 30% of hires this year via referrals.
• Minimal travel to client sites.
• Unlimited time off, business closure during winter holidays, promoting work/life balance.Job Summary: The Regulatory Affairs Specialist develops and executes international strategies for regulatory approval of medical devices. Responsibilities include:
  • Preparing and submitting regulatory documentation (e.g., PMAs, IDEs, 510(k)s, technical files, design dossiers).
  • Managing documentation for worldwide regulatory approvals.
  • Conducting Post Market Surveillance activities, including CAPA, risk management, recalls, and complaints.
  • Handling submissions such as PMA, 510(k), de novo, IDE, HDE.
  • Supporting market entry, due diligence, UDIs, and CER reporting.
  • Reviewing device labeling and marketing for compliance.
  • Collaborating with cross-functional teams on product development and manufacturing.
  • Communicating with regulatory bodies like FDA, Health Canada, notified bodies.
  • Participating in project reviews and regulatory due diligence.
  • Anticipating regulatory challenges and developing solutions throughout the product lifecycle.About the Company:
    • Grew Regulatory and Quality teams significantly in 2018.
    • High retention rate (> 95%).
    • Hiring for direct hire roles; contractors considered.
    • Offers comprehensive benefits: health, dental, vision, 401K, disability insurance.Minimum Qualifications:Education: Bachelor's degree or equivalent, ideally in biomedical engineering or life sciences; Regulatory Affairs Certification (US or EU) preferred; RAPS certification preferred.Experience: 3-10 years in regulatory and/or quality assurance for medical devices.Skills: Team player, proactive, able to meet deadlines, handle multiple projects, and make quick decisions in a fast-paced environment.Full corporate benefits include 401K, annual bonus, unlimited time off, EAP, and more.
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Keywords: Biolink360, Los Angeles , Principal Regulatory Affairs Specialist-Remote Based, Other , Santa Barbara, California