Quality Systems Director | OUS | IVDR

Director, Global Quality Systems / OUS IVDR

This role will lay the groundwork and build out our client partner’s international compliance measures in anticipation of international product launch.

A CB Insights Digital Health 150 company is seeking a Director, OUS Quality Systems, based (generally in the greater Boston area), and remote/hybrid you will:

• Provide leadership and management for all international quality assurance and related commercial and pre-commercial Quality activities within the company.

• Lead and build efficient compliance processes and communication measures across the organization with a focus on the company’s developing international markets.

You must be:

A proven Quality Leader with experience in compliance for complex medical technology, biotech or pharmaceutical product/s development and commercialization under international regulatory compliance guidelines- IVDR, Japan, Health Canada, Brazil and other OUS regulations.

Basic Requirements:

BS Degree in a scientific or engineering field and advanced degree preferred but not required.

12+ years of relevant experience in the medical device, digital health, or biotechnology/pharmaceutical industry

Minimum 5 years of proven direct leadership experience in the Quality leader role

Global Quality Systems Development experience is required. Recent experience with IVDR planning and implementation is strongly preferred.

Experience with QA oversight of commercial products

Expert knowledge of global regulations for the development and marketing of medical device products (US, EU and all other major international regulatory compliance requirements)

Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards and demonstrated implementation

Previous experience with building QA systems and company-wide or global SOP systems

If you are interested in exploring other opportunities in the space, feel free to reach out, we are easily contacted via linkedin, please reach out to us. Have a nice day.

Agile Search Inc.