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.