Regulatory Affairs Specialist or Senior Specialist
My client develops and manufactures medical devices for tissue repair and regeneration for the areas of oral surgery, neurosurgery, and orthopedic-spine surgery. This company has multiple approved products with several more programs in development. With anticipation to grow over 30% over the next year, they are looking for a Regulatory Affairs Specialist or Senior Specialist to lead submissions and interact directly with global health authorities. You will experience significant growth within a professional environment where everyone has the ability to communicate collaboratively.
Responsibilities:
- Prepare and contribute to the preparation of regulatory submissions for both domestic and international regulatory assessments for both Class II and Class III medical device submissions
- Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance requirements, or clarification and follow-up of submissions under review
- Compile summary technical documentation (STED) packet for specific distributor requests to support international product registration
- Determine, plan and execute regulatory status reporting of engineering change orders and provide advice to project teams on appropriate pathways to marketing
- Participate in cross-functional team meetings throughout product development as a regulatory representative
Knowledge and Skills:
- Minimum 3-5 years’ experience in Regulatory Affairs specific to Medical Devices and/or biotechnology companies
- Minimum bachelor’s degree in a scientific discipline
- Must be familiar with FDA requirements and EU regulations related to medical devices and/or combination products
- Must have experience filing medical device submissions as well as facilitating development activities
- Must have Class II device experience (animal based devices a plus)
- Must be able to write and present a submission