Senior Regulatory & Quality Consultant

ARx Recruitment Services; United Kingdom; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

A reputable consultancy in the medical device sector is seeking experienced Consultants and Senior Consultants to guide clients through regulatory submissions and quality management systems. Candidates should have proven expertise in Quality Assurance and Regulatory Affairs, working independently and collaboratively. This position offers a flexible, project-based role with competitive remuneration.

Benefits

Flexible project-based role

Competitive remuneration

Qualifications

• 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.

Responsibilities

• Advise clients on CE marking and FDA submissions.
• Provide practical support to ensure compliance.
• Implement and maintain Quality Management Systems.

Skills

Quality Assurance

Regulatory Affairs

Client Management

Problem-Solving

Job description

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.