Regulatory Affairs Manager

Regulatory Affairs Manager

Are you passionate about regulatory affairs and want to play a key role in bringing innovative medical devices to market? Join our growing, dynamic team where your work directly impacts patient safety and healthcare innovation.

What You'll Do:

• Lead and inspire our Regulatory Affairs team, helping everyone thrive while managing registrations, certifications, and compliance.
• Drive regulatory strategies and ensure products meet all necessary standards.
• Collaborate closely with R&D, Quality, Clinical, Marketing, and Sales to bring new ideas to life.
• Manage submissions, approvals, and change notifications with regulatory authorities.
• Ensure products, labeling, and packaging are compliant, including UDI and post-market activities.

What We're Looking For:

• A degree in science, medical, or engineering discipline.
• Experience in medical device regulatory affairs (MDD, MDR, IVDD, IVDR, UK MDR, ISO 13485).
• Expertise in CE/UKCA marking, technical documentation, and regulatory submissions.
• Strong project and people management skills, with a collaborative, proactive approach.

If you enjoy leading a team, solving challenges, and making a tangible difference in patient care, this role is for you!