Regulatory Affairs Consultant (Freelance)
Regulatory Affairs Consultant (Freelance)
Location: Brussels, Belgium (hybrid)
Length: 12 months (possibility of extension)
Start Date: June 2026
Key Responsibilities
- Support the development and maintenance of regulatory strategies for new and existing medical device products, including involvement with a Class IIb device.
- Contribute to regulatory project activities, working closely with regulatory colleagues and cross‑functional teams such as R&D and Clinical Affairs.
- Act as a technical regulatory subject matter expert, providing input and guidance to internal teams as required.
- Assist with regulatory inspections and external audits, including preparation of technical documentation for FDA and ISO assessors.
- Support interactions with Notified Bodies and contribute to global product registration and submission activities.
- Ensure assigned products and activities comply with applicable regulatory, quality, and internal standards.
- Operate in line with the Quality Management System and comply with site environmental, health, and safety requirements.
- Communicate effectively with Notified Bodies, Competent Authorities, and other regulatory agencies under supervision or guidance where appropriate.
Requirements
- Bachelor's degree (or equivalent) in a scientific discipline such as Chemistry, Biology, or Life Sciences.
- Prior Class IIb medical device experience is essential and ideally combination product experience.
- Regulatory affairs experience within the medical device or healthcare manufacturing sector.
- Strong knowledge of ISO 13485, EMC, MDD 93/42/EEC, MDR 2017/745 and FDA QSR.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.