Senior Regulatory Affairs Specialist
$99,000–$129,000 year
RemoteUnited States
Job Summary
Develop sound global, regional, and multi-country regulatory strategies for new and modified medical devices. Prepare international and domestic filings/registrations to established timelines, anticipate regulatory obstacles throughout the product lifecycle, and interact with regulatory authorities to ensure submission approval. Represent Regulatory Affairs on assigned projects, provide guidance to cross-functional teams, and coordinate with international contacts on product changes and registration maintenance. Review and approve product design changes, author or revise SOPs, and manage product recalls and communications. Monitor the impact of changing global regulations on submission strategies and perform other quality and regulatory-related duties as assigned.
Required Qualifications
- Bachelor's degree (B.A./B.S.)
- 3 years of Regulatory Affairs experience in the medical device industry
- Product development or sustaining/life cycle management experience
- Exceptional communication (written and oral) skills
- Exceptional problem-solving skills
- Exceptional organizational skills
- Willingness to travel when required, up to 10%
Desired Qualifications
- Familiarity with global medical device regulations; 21 CFR 820, MDD/CMDR, EU MDR, UKCA, ASIA PAC, LATAM, etc.
- Demonstrated understanding of ISO 13485, ISO 14971, ISO 10993, GDPR, HIPAA and other international regulations/directives/standards
- Master's or other advanced degree in a related field
- SaMD/MDSW, wearable, and OTC medical device experience
- Project management skills
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