Regulatory Affairs Specialist (FDA/Medical)

Regulatory Affairs Specialist (Medical)

Location: San Francisco, CA

Job Overview:

The Regulatory Affairs Specialist will be responsible for overseeing and managing regulatory submissions, ensuring that the company's medical devices comply with relevant national and international regulations, including FDA, EU MDR, and other global standards. This role will involve working closely with cross-functional teams, including R&D, quality, and manufacturing, to support product development and ensure regulatory compliance throughout the product lifecycle.

Key Responsibilities:

• Regulatory Submissions: Prepare and submit regulatory filings such as 510(k)s, PMAs, technical files, and design dossiers to regulatory agencies (FDA, EU, etc.).
• Compliance: Ensure compliance with regulatory requirements and maintain knowledge of current and emerging regulations in key markets (e.g., US, EU, APAC).
• Document Management: Maintain regulatory documentation, including risk management files, product labeling, and marketing materials.
• Cross-functional Collaboration: Work with R&D, quality assurance, and manufacturing teams to integrate regulatory requirements into product development processes.
• Post-Market Surveillance: Support post-market surveillance activities, including adverse event reporting and field corrective actions, as required.
• Communication: Act as a point of contact for regulatory agencies, preparing responses to questions and deficiencies during the regulatory review process.
• Audits and Inspections: Assist in the preparation for and management of regulatory agency audits and inspections.
• Training and Education: Provide regulatory guidance and training to internal teams to ensure understanding and adherence to regulatory requirements.

Key Qualifications:

Experience:

• Minimum of 3-5 years of experience in regulatory affairs, ideally within the medical device or MedTech industry.
• Experience with regulatory submissions for Class II/III medical devices (e.g., 510(k), PMA, CE marking).
• Familiarity with FDA, EU MDR, ISO 13485, and other relevant regulations.

Skills:

• Strong understanding of regulatory processes, guidelines, and standards (FDA, CE Marking, EU MDR).
• Excellent written and verbal communication skills with attention to detail.
• Proficiency in managing and organizing large amounts of technical data and regulatory documentation.
• Ability to work effectively in cross-functional teams and manage multiple projects simultaneously.
• Strong analytical and problem-solving skills.

Preferred Qualifications:

• RAC (Regulatory Affairs Certification) or equivalent certification.
• Experience with international regulatory submissions (e.g., China NMPA, Japan PMDA).
• Knowledge of quality management systems (QMS) such as ISO 13485 and FDA’s Quality System Regulation (QSR).
• A bachelors degree in a relevant discipline.

Working status:

• This position is based in San Francisco, CA, with hybrid work options.
• Occasional travel may be required for regulatory agency meetings or audits.

Compensation and Benefits:

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• 401(k) with company match.
• Opportunities for professional development and continuous learning.