Regulatory Affairs Manager - Proclinical Staffing : Job Details

Regulatory Affairs Manager - Permanent - Remote

Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. This is a permanent role based remotely out of the San Francisco Bay Area.

Primary Responsibilities:

In this role, you will provide direct support to company operations for their globally distributed products. This role is a global regulatory position, working closely with site Quality, R&D, Operations, and regional RA peers to support global licensing and registrations, and to ensure the effective execution and management of changes.

Skills & Requirements:

• Bachelor's degree in a scientific discipline is required. Advanced degree is preferred.
• 10+ years of experience in medical device industry. 5+ years of experience in Electrical/Active medical device industry.
• 5+ working knowledge of appropriate global medical device regulations, requirements, and standards.
• 2+ years of people management: direct & indirect.
• Should have experience of independently authoring complete 510k submissions, Health Canada Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above).
• Experience in participating in national or international standards activities.
• Must be eligible to work in the US.

The Manager, Regulatory Affairs will:

• Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product portfolio.
• Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
• Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE Marking, global product registrations, and clinical evaluations.

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-###-#### or [email protected].

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.