Job Type: Full time
Job Title: Regulatory Affairs Manager
Location: Onsite - San Diego, CA
Position Summary:The Regulatory Affairs Manager will support the preparation, review, and submission of regulatory documentation for medical device products, ensuring compliance with applicable regulatory requirements including FDA, ISO 13485, and other global standards. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
Key Responsibilities: - Prepare, review, and coordinate the submission of regulatory documents including 510(k), technical files, and other filings to regulatory agencies.
- Ensure product compliance with FDA regulations, ISO 13485, and applicable international standards.
- Provide regulatory support to product development teams by offering guidance on applicable regulations and documentation requirements.
- Stay current on changes in regulatory requirements and assist in assessing the impact on company processes and products.
- Perform regulatory assessments for product changes and propose appropriate regulatory pathways.
- Maintain documentation and records of all regulatory submissions and correspondence.
- Support the preparation for regulatory agency meetings, audits, and inspections.
- Collaborate with internal departments such as R&D, Quality, and Operations to ensure regulatory deliverables are met in a timely manner.
RequirementsEducation: - Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field required.
- Master's degree preferred.
Professional Experience: - 5-7 years of regulatory affairs experience within the medical device or IVD industry.
- Working knowledge of 510(k) submissions and regulatory documentation processes.
- Experience interacting with FDA and other regulatory agencies preferred.
Skills & Competencies: - Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, and medical device regulatory requirements.
- Strong organizational and project management skills with the ability to manage multiple projects and priorities.
- Excellent communication, problem-solving, and attention to detail.
- Ability to work collaboratively in cross-functional teams and manage document workflows.
Benefits - Highly competitive compensation package.
- Comprehensive medical, dental, and vision insurance.
- 401(k) plan with generous company contributions.
- Flexible paid time off (PTO) policy.
- Additional substantial benefits.
