Regulatory Affairs Leader: 510(k) Submissions for GI Devices

Meet Life Sciences; San Francisco (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Meet Life Sciences, a small medical device company in the SF Bay area, seeks a Regulatory Affairs Manager/Director to lead a pivotal FDA 510(k) submission for GI-related devices. You will drive premarket regulatory strategy, coordinate cross-functional teams, and ensure timely responses to FDA inquiries while supporting ongoing post-market activities.

The role requires extensive FDA experience, ISO 13485 and 21 CFR knowledge, and the ability to manage complex projects.

Qualifications

• Bachelor's or Master's degree in medical technology, life sciences or similar.
• 8+ years regulatory affairs experience in the medical device industry.
• Proven track record for authoring/supporting FDA 510(k) submissions and premarket FDA submissions.
• Strong experience (3+ years) interacting directly with the FDA.
• Experience supporting FDA regulatory submissions for GI-related medical devices preferred.
• Comprehensive knowledge of regulatory requirements for medical devices (ISO 13485:2016, ISO 14971:2019, 21 CFR).
• US FDA 21 CFR 807 knowledge is a must; 803/806/820 a plus.
• Proven project management experience and proficiency with regulatory systems.

Responsibilities

• Coordinate premarket regulatory activities and facilitate cross-functional information flow.
• Prepare responses to FDA inquiries and support submissions (premarket and post-market).
• Collaborate with R&D, QA, Clinical Affairs and other SMEs to gather and review data for submissions.
• Support risk management activities and post-market surveillance.
• Maintain knowledge of applicable FDA regulations, ISO standards, and QMS compliance.
• Assist regulatory project planning, execution, and process improvements.
• Review submission materials for accuracy and compliance; escalate deficiencies.
• Support QMS activities including CAPA, audits, and inspections.
• Participate in audits/inspections to ensure regulatory compliance.

Education

Bachelor's or Master's degree in medical technology, life sciences or similar

8+ years regulatory affair experience in the medical device industry

FDA interactions (3+ years)

Strong knowledge of ISO 13485:2016, ISO 14971:2019 and 21 CFR

Job description

Meet Life Sciences, a small medical device company in the SF Bay area, seeks a Regulatory Affairs Manager/Director to lead a pivotal FDA 510(k) submission for GI-related devices. You will drive premarket regulatory strategy, coordinate cross-functional teams, and ensure timely responses to FDA inquiries while supporting ongoing post-market activities.

The role requires extensive FDA experience, ISO 13485 and 21 CFR knowledge, and the ability to manage complex projects.