Submission SME - Medical Device

Tunnell Consulting   •  

Rockville, MD

8 - 10 years

Posted 212 days ago

Key Responsibilities:

  • 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

Desired Qualifications:

  • 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.

8920