Are you a self-starter with expertise in Quality Assurance and Regulatory Affairs within the Medical Devices and IVD industries? Do you thrive in a hands-on consultancy role, working closely with clients to navigate complex regulatory landscapes? If so, we have an exciting opportunity for you!

About the Role

We are seeking Consultants and Senior Consultants to provide expert regulatory and compliance support to a diverse client base. You will play a crucial role in guiding medical device and IVD companies through regulatory submissions, quality management systems, and compliance strategies.

Key Responsibilities:

✔️ Advise clients on CE marking, FDA submissions, PMA, IDE, MHRA approvals, and other global regulatory pathways.
✔️ Provide practical, hands-on support to ensure products meet international compliance requirements.
✔️ Implement and maintain Quality Management Systems (QMS).
✔️ Stay ahead of evolving medical device and IVD regulations.
✔️ Work independently while also collaborating within a dynamic and client-focused consultancy team.

About You

✅ Proven experience in Quality Assurance and/or Regulatory Affairs within Medical Devices or IVDs.
✅ Strong understanding of international regulatory requirements (CE, FDA, MHRA, NICE, etc.).
✅ Ability to work independently with minimal oversight – we need someone who can hit the ground running.
✅ Excellent problem-solving and client management skills.
✅ Passion for delivering efficient, strategic, and compliant solutions.

Why Join?

🔹 Work with a consultancy that is trusted by the medical device industry.
🔹 Enjoy a flexible, project-based role tailored to your expertise.
🔹 Be part of a collaborative, hands-on team where your knowledge makes a real impact.
🔹 Competitive remuneration based on experience and project scope.

If you're a seasoned professional who thrives in a fast-paced, client-driven environment, we want to hear from you!