Regulatory Affairs Consultant

Stevenson Search Partners; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Stevenson Search Partners partners with a global medical device company to fill a Regulatory Affairs Consultant role in San Francisco, focusing on FDA submissions and pre-submission activities.

The ideal candidate has 5+ years in regulatory affairs, deep FDA knowledge (21 CFR 807; 803/806/820 a plus), and hands-on experience with software/AI submissions to FDA. Collaboration with R&D, QA, and Clinical Affairs is essential.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5+ years in regulatory affairs and 8+ years overall industry experience.
• Knowledge of US FDA 21 CFR 807; 803/806/820 knowledge is a plus.
• Experience with software and AI submissions to the FDA.

Responsibilities

• Coordinate communication for premarket and post-market regulatory activities.
• Prepare responses to FDA inquiries and submissions.
• Collaborate with R&D, QA, Clinical Affairs, and other teams to gather submission data.
• Identify regulatory risks and support mitigation strategies.
• Support QMS activities including CAPA, complaints, and audits.
• Participate in audits/inspections to ensure ISO 13485 and regulatory compliance.
• Manage regulatory projects and drive process improvements and tools implementation.

Education

Bachelor's degree in Life Sciences

Tools

FDA submission software

Job description

Our On-Demand Talent Solutions team is partnering with our valued client to identify a Regulatory Affairs Consultant to support a global medical device company who focuses on gastrointestinal systems. The ideal candidate has extensive FDA regulatory experience, and thrives in a collaborative environment.

Summary:

This consultant will be responsible for preparing regulatory FDA submissions for our client's products including pre-submissions.

Responsibilities:

• Coordinate communication and information flow for premarket and post-market regulatory activities.
• Prepare responses to FDA inquiries and requirements and support regulatory documentation and submissions.
• Partner with R&D, Quality Assurance, Clinical Affairs, and other cross-functional teams to gather and integrate submission data.
• Identify and assess regulatory risks, support risk control measures, and develop mitigation strategies.
• Support Quality Management System (QMS) activities, including CAPA, customer complaints, and internal audits.
• Participate in internal/external audits and inspections, ensuring compliance with the QMS, ISO 13485, and other applicable regulations.
• Manage regulatory projects and information requests while supporting process improvements and implementation of regulatory tools.

Qualifications

• Bachelor's degree in Life Sciences, Medical Technology or a related field required.
• 5+ years of experience in regulatory affairs and 8 years of overall industry experience.
• Knowledge of US FDA 21 CFR 807 is a must. US FDA 21 CFR 803/806/820 knowledge is a plus.
• Experience with software and AI submissions to the FDA.