Senior Manager Regulatory Affairs

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

A small, commercial stage medical device company in the SF Bay area is seeking a Regulatory Affairs Manager or Director to lead a critical 510(k) FDA submission. The company is developing innovative surgical devices to detect gastrointestinal diseases. This role’s primary function will be to prepare premarket FDA regulatory submissions for class II medical device products including pre-submissions. You will work closely with cross-functional teams to ensure timely execution of projects/response to inquiries and support the Head of Regulatory in addressing internal and external information requests related to premarket/post market activities.

Responsibilities:

• Coordinate premarket regulatory activities and facilitate communication and information flow across cross-functional teams.
• Prepare responses to FDA inquiries and support premarket and post-market regulatory submissions, documentation, and reporting.
• Collaborate with R&D, Quality Assurance, Clinical Affairs, and other SMEs to gather, review, and integrate data for regulatory submissions.
• Support product risk management activities, including identification and assessment of risks, implementation of risk controls, and post-market surveillance.
• Maintain knowledge of applicable FDA regulations, ISO 13485, and other regulatory standards to ensure ongoing compliance.
• Support regulatory project planning, execution, and tracking, including process improvement initiatives to optimize regulatory procedures.
• Assist the Sr. Director of Regulatory Affairs with internal and external information requests related to premarket and post-market activities.
• Review regulatory submission materials for accuracy, completeness, and compliance; identify and elevation deficiencies to appropriate SMEs.
• Support Quality Management System activities, including CAPA, Customer Complaints, Internal Audits, and regulatory inspections.
• Participate in internal and external audits and inspections, ensuring processes, procedures, and documentation comply with the QMS, ISO 13485, and applicable regulations and Internal Audits.
• Participates in internal/external audits and inspections, and ensures that company procedures, processes and documentation meet the requirements of the Quality Management System, ISO 13485 and other applicable regulations.

Required Experience & Qualifications:

• A bachelor’s or master’s degree in medical technology, life sciences or similar.
• A minimum of 8 years of regulatory affair experience in the medical device industry experience.
• A proven track record for authoring/supporting successful FDA 510(k) submissions and premarket FDA submissions.
• Strong experience (3+ years) interacting directly with the FDA.
• Experience supporting FDA regulatory submissions for gastrointestinal (GI) related medical device products strongly preferred.
• Comprehensive knowledge of regulatory requirements for medical devices, such as ISO 13485:2016, ISO 14971:2019 and 21CFR820.
• US FDA 21 CFR 807 knowledge is a must.
• US FDA 21 CFR 803/806/820 basic knowledge would be a plus.
• Proven project management experience, including planning, execution, and monitoring of projects.
• Strong knowledge of regulatory requirements and risk management principles.
• Proficiency in regulatory affairs software and systems.