Job Title - Regulatory Affairs Specialist
Job location type - In person
Location - San Diego, CA 92121
Job type - 12 months contract
Shift Schedule - 1st shift, Monday-Friday
About the Role
We are seeking a highly experienced Medical Device Regulatory Affairs Specialist to support regulatory activities throughout the product lifecycle. This role will focus on regulatory change assessments, U.S. medical device submissions, regulatory strategy, risk management, and regulatory compliance within a regulated medical device environment.
Key Responsibilities
- Lead and support regulatory change assessments for medical devices, manufacturing processes, labeling, and product modifications
- Prepare, review, and support U.S. medical device regulatory submissions and related documentation
- Develop and implement regulatory strategies for new product development, product changes, and lifecycle management
- Partner with cross-functional teams including R&D, Quality, Manufacturing, Engineering, Clinical, and Marketing
- Provide regulatory guidance on manufacturing changes, line extensions, labeling, and product modifications
- Monitor and interpret applicable medical device regulations, regulatory policies, and industry requirements
- Support risk management activities and regulatory impact assessments
- Contribute to continuous improvement initiatives related to regulatory processes and compliance
- Support product planning and implementation activities from a regulatory perspective
- Help ensure regulatory requirements are addressed for new product approvals and continued compliance of marketed products
- Serve as a Regulatory Affairs representative on cross-functional project teams
- Provide regulatory guidance and interpretation to product development and marketing teams
- Monitor regulatory intelligence and emerging requirements that may impact products and business activities
Required Qualifications
- 7+ years of experience in Medical Device Regulatory Affairs
- Strong experience with regulatory change assessments
- Working knowledge of U.S. medical device regulatory submissions
- Experience supporting regulatory strategy and product lifecycle management
- Knowledge of medical device regulations, regulatory policies, and regulatory intelligence
- Experience working with cross-functional teams in a medical device or regulated product environment
- Strong understanding of risk management and regulatory impact assessments
- Excellent written and verbal communication skills
- Strong analytical, organizational, and problem-solving skills
Preferred Qualifications
- Experience advising teams on manufacturing changes, line extensions, labeling, and product modifications
- Experience supporting new product development and commercialization
- Familiarity with regulatory requirements for marketed medical devices and product lifecycle activities
- Experience identifying regulatory implications of changes to products, processes, or documentation
- Experience contributing to regulatory process improvement and compliance initiatives