- Posted 13 November 2025
- LocationSanta Ana
- Job type Permanent
- Reference225590
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Regulatory Manager
Job description
Position Summary
We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities for our medical device portfolio. This role will be instrumental in driving regulatory strategies for both new product development and lifecycle management, ensuring alignment with US FDA and EU regulatory requirements.
Key Responsibilities
Support development and execution of regulatory strategies for new product development and sustaining engineering projects.
Prepare, submit, and manage regulatory applications to the US FDA (e.g., 510(k), PMA) and EU Notified Bodies (e.g., Technical Files, Design Dossiers). Interact with regulatory agencies as needed to address submission deficiencies and requests for additional information.
Serve as the regulatory representative on cross-functional product development teams, providing guidance on regulatory requirements and risk mitigation.
Maintain regulatory compliance throughout the product lifecycle, including change assessments and post-market surveillance.
Collaborate with internal teams (R&D, Quality, Clinical, Manufacturing, Marketing, Consultants) to ensure regulatory requirements are integrated into product development and documentation.
Monitor and interpret evolving global regulatory requirements and communicate impact to internal stakeholders.
Support audits and inspections by regulatory authorities and notified bodies.
Contribute to regulatory intelligence and strategy development for global market access.
Preferred Qualifications
Bachelor’s degree in a scientific, engineering, or related discipline (advanced degree preferred).
7–10 years of regulatory affairs experience in the medical device industry.
Proven track record of successful submissions to, and experience interacting with, US FDA and EU Notified Bodies.
Experience supporting both new product development and sustaining activities.
Strong understanding of global medical device regulations (e.g., FDA CFR, EU MDR).
CMC (Chemistry, Manufacturing, and Controls) experience is a plus but not required.
Demonstrated leadership experience in managing regulatory teams or projects.
Excellent communication, project management, and problem-solving skills.
RAC certification or equivalent is a plus.
We are seeking an experienced and strategic Regulatory Affairs Manager to support global regulatory submissions and compliance activities for our medical device portfolio. This role will be instrumental in driving regulatory strategies for both new product development and lifecycle management, ensuring alignment with US FDA and EU regulatory requirements.
Key Responsibilities
Support development and execution of regulatory strategies for new product development and sustaining engineering projects.
Prepare, submit, and manage regulatory applications to the US FDA (e.g., 510(k), PMA) and EU Notified Bodies (e.g., Technical Files, Design Dossiers). Interact with regulatory agencies as needed to address submission deficiencies and requests for additional information.
Serve as the regulatory representative on cross-functional product development teams, providing guidance on regulatory requirements and risk mitigation.
Maintain regulatory compliance throughout the product lifecycle, including change assessments and post-market surveillance.
Collaborate with internal teams (R&D, Quality, Clinical, Manufacturing, Marketing, Consultants) to ensure regulatory requirements are integrated into product development and documentation.
Monitor and interpret evolving global regulatory requirements and communicate impact to internal stakeholders.
Support audits and inspections by regulatory authorities and notified bodies.
Contribute to regulatory intelligence and strategy development for global market access.
Preferred Qualifications
Bachelor’s degree in a scientific, engineering, or related discipline (advanced degree preferred).
7–10 years of regulatory affairs experience in the medical device industry.
Proven track record of successful submissions to, and experience interacting with, US FDA and EU Notified Bodies.
Experience supporting both new product development and sustaining activities.
Strong understanding of global medical device regulations (e.g., FDA CFR, EU MDR).
CMC (Chemistry, Manufacturing, and Controls) experience is a plus but not required.
Demonstrated leadership experience in managing regulatory teams or projects.
Excellent communication, project management, and problem-solving skills.
RAC certification or equivalent is a plus.