- Point person with clinical sites, reviews and prepares clinical study protocol, including data management in support of 510K submissions.
- Facilitates search and qualification of clinical sites in the US including site start-up activities and study protocol training
- Manages information to be submitted to regulatory authorities and acts as liaison.
- Oversite of company’s QMS, submitting on time, within budget, and meeting regulatory requirements
- Interprets regulations and provides sales, marketing, and global regulatory teams with constructive regulatory guidance and recommendations.
- Support completion of product license applications, develop content/format for regulatory submissions, such as 510(k)’s
- Serve as Regulatory Affairs representative in review and approval of marketing/promotional, sales training, packaging & labeling materials
- Participates in obtaining 510(k) clearance, contributes to writing pre-submissions and 510(k) submittals, and interacts with FDA in matters related to pre-submissions, 510(k) files and follow-up meetings
- M.S. with 4 to 6 years of experience; B.S. degree with 7 to 9 years of experience
- Analytical thinking and problem solving skills
- Excellent communication skills, verbal and written
- Excellent interpersonal skills and leadership potential with excellent negotiation skills
- Computer literate with in-depth knowledge of the electronic systems for electronic storage and submission
- Expert knowledge of Medical Device regulations
- Familiar with product registrations (globally)
- Experience in GLP, IVD, the biomaterials and/or animal tissue industry preferred.