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!
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