Regulatory Affairs Specialist Manager

Posted 6 days ago by Kelly Services
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An exciting new opportunity has risen with a medical technology start-up who are looking for pioneers in their field to join the company during this exciting phase of growth.

This is the perfect opportunity for anyone working within Medical Device Regulatory Affairs, who wants to transfer their skills to the exciting world of Medical Technology!

We are looking for creative individuals with a strong technical background who will redefine the world of healthcare.

What are we looking for?

- Regulatory Affairs Manager (Medical Devices or Medical Technology)
- Support the Regulatory Lead in the creation and running of the Regulatory Affairs team
- Be involved in the strategic planning of developing the regulatory affairs department
- Advise on regulatory strategy for new products or product features
- Manage, plan and submit regulatory submission documentation in different countries and with partners
- Work closely with Regulatory Authorities for submissions, listings, incident reporting etc.
- Monitor regulatory developments and provide regulatory intelligence for Software as a Medical Device (SaMD)
- Support the build-up of a regulatory affiliates organisation

Requirements for the ideal candidate:

- Understanding of EU and US regulatory requirements, current and future (e.g. MDR)
- Ideally, detailed regulatory expertise in one other region, e.g. Asia
- Regulatory submission experience
- Experience with stand-alone healthcare software / Software as a Medical Device (SaMD)
- Understanding of Agile development and the Software Development Life Cycle
- Willingness to work across teams and in related areas, e.g. Quality, Safety and Compliance
- Experience of start-up/ high-growth environment

Kelly Services are an Equal Opportunities employer and welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age. Kelly Services are acting as an Employment Business in relation to this job.

Reference: 38684653

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