Regulatory Compliance Specialist ll 5996

Recruiter
ComServe Solutions, LLC
Location
Bridgewater
Salary
Competitive
Posted
03 Jul 2022
Closes
31 Jul 2022
Employer Sector
Scientific
Contract Type
Permanent
Hours
Full Time
Travel
None

We are looking for a Regulatory Compliance Specialist in the Bridgewater, New Jersey area. Regulatory subject-matter-expertise with medical device and/or combination products experience preferred. This is a remote position.

Note: This location requires candidates to be fully vaccinated for Covid-19.

Requirements:

  • Working on regulatory projects for combination products; specifically, auto-injectors prefilled syringes, and PFS safety systems.
  • Contribute to the development and implementation of regulatory strategy for specific projects.
  • Communicate regulatory development and submission strategies, regulatory risks, and serve as the regulatory representative on project teams.
  • Perform reviews of the device constituent part of combination products for regulatory submissions.
  • Act as regulatory subject matter expert on combination products and medical devices.
  • Familiarity with submission requirements for medical devices and/or combination products (PMA, 510(k), BLA, NDA, etc.). Regulatory Skills/experience: - Experience with regulatory strategy for drug delivery systems (medical devices).


Education and Experience:

Bachelor's Degree required.

Years of Experience: 5+ Years

  • Experience with medical devices/combination products in medical device/pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment.
  • Thorough understanding of scope and requirements for medical devices.

Preferred Experience:

  • Direct experience with submissions of combination products with an auto-injector or prefilled syringe.
  • Direct Experience with submission of medical devices, e.g., 510(k) Pre-market Notification, PMA, IDE or combination products with device constituent parts submitted under a drug application i.e. BLA or NDA. Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Knowledge and understanding of applicable regulations and international standards.

Please reply with your resume for review. We look forward to speaking with you!

ComServe is an Equal Opportunity employer - Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability or protected veteran status.