What are the responsibilities and job description for the Senior Regulatory Affairs Specialist position at BIOBOSTON CONSULTING?
Job Title: Senior Regulatory Affairs Consultant (IVD / 510(k))
Location: Remote (U.S.) – East Coast preferred (NH)
Job Type: Contract
Start Date: ASAP
Duration: 3–6 months (potential extension)
Role Description
We are seeking a Senior Regulatory Affairs professional with strong experience in In Vitro Diagnostics (IVD) to support an active FDA submission program for a diagnostics company based in New Hampshire.
This is a hands-on role for someone who can execute regulatory work while also providing guidance and direction during a period of internal transition.
Key Responsibilities
- Lead and support 510(k) submission activities for IVD products
- Prepare, review, and compile regulatory documentation (e.g., technical files, summaries, responses)
- Work within the FDA eSTAR submission framework
- Provide regulatory strategy input and guidance to internal teams
- Collaborate with cross-functional teams (clinical, R&D, quality)
- Support responses to FDA questions and requests (RAIs)
- Ensure compliance with FDA regulations and applicable standards
Required Qualifications
- 8–10 years of Regulatory Affairs experience in medical devices or diagnostics
- Strong experience with IVD products and diagnostic assays
- Proven track record with 510(k) submissions
- Experience with FDA eSTAR preferred
- Ability to work independently and provide strategic input
- Strong communication and cross-functional collaboration skills
Preferred Qualifications
- Experience with molecular diagnostics or complex assay systems
- Familiarity with instrument assay regulatory pathways
- Prior consulting experience or ability to step into fast-paced environments quickly
- East Coast location or ability to travel occasionally for onsite meetings