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.