Director Global Regulatory Affairs

Are you an experienced, highly organized and results driven Regulatory Affairs leader within the IVD space?

I am partnered with an established, medium sized IVD company specialized in infectious disease, clinical chemistry, coagulation and diabetes.

We are proactively looking for a Director of Regulatory Affairs to oversee all regulatory activities for new and mature products to ensure alignment and compliance with international registration requirements and company policies.

This position can be based out of San Diego or Boston, and there will be flexibility for some remote working.

The RA Director will be responsible for:

• Developing regulatory strategies and in partnership with the project teams, oversee implementation of plans to a successful outcome
• Supporting the processes and procedures for bringing In Vitro Diagnostic medical product(s) through the design control process from feasibility to product approvals/clearance
• Ensuring RA organization support for currently marketed products
• Act as a primary contact with regulatory agencies for global product registrations, inclusive of the Pre-Sub process

What are we looking for?

• BS/BA degree in a scientific discipline and/or Regulatory Affairs is a MUST
• Masters degree would be preferred (Regulatory Affairs
• 10+ years regulatory experience
• Minimum 5 years leadership experience, managing teams of up to 10 people
• Extensive knowledge of global regulations (US FDA, Canada, EMEA etc)
• Extensive experience managing complex submissions and technical documentation (instrumentation, hardware, software and reagents)
• Comprehensive knowledge of Design Control requirements
• Experience with point of care, clinical chemistry etc

This position offers a strong base, bonus and great benefits.