Principal Regulatory Affairs Specialist - Remote Based
Our 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.