This is a critical hire for our client and will be responsible for the global regulatory strategy of a new product. This is a hands-on role that will oversee regulatory submissions from planning stages through execution, preparing for global launch. In this role you’ll adhere to timelines, budget, and quality, while working in a relatively autonomous, fast-paced role.
Senior Regulatory Affairs Professional (Director Level)
Westwood, MA (Relocation Provided)
DOE; $185-200K+, 10-15% bonus, 4 weeks Vacation, Full Benefits
What makes this role unique: A 10+ year client of ours has acquired an exciting technology company and is ramping up to commercialize the product; development, research, clinical, regulatory, etc – all of this ground-floor opportunities to create & build, but have the stability of working for a multi-billion dollar profitable business! Start-up feel, big-business backing and support. This role is within a leading medical diagnostic company, that offers cutting edge technology, machines, and rapid testing solutions at physicians’ fingertips.
- Bachelor of Science required; in a technical capacity (Science based - strongly preferred, others will be considered based on overall relevant experience)
- 8-15+ years of Regulatory Affairs experience; with experience in a medical device, medical instrument, or biotech industry (required)
- Experience with U.S. FDA 510k and/or PMA submissions and interaction with FDA reviewers required.
- Knowledge and experience with global registrations strongly preferred (EU, etc)
- RAC (Regulatory Affairs Certification) desired, not required
- Strong leadership, interpersonal, communication and organizational skills required.
- Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities.
- Must be able to set priorities as well as adapt to changing priorities