Director RA

Manager/Director, Regulatory Affairs

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 escalate 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.