Regulatory Affairs and Compliance Specialist

4 days ago

Mildenhall, United Kingdom Serve Talent Full time

Serve Talent are proud to be working exclusively with a successful Medical Device manufacturing business who are looking to recruit a Regulatory Affairs and Compliance Specialist for their facility based in Mildenhall, Suffolk.

Reporting into the Head of Medical and working alongside the wider Research & Development team, you'll be responsible for the creation of design assurance documentation for a variety of innovative Medical Devices.

Responsibilities will include but not be limited to:

- Assist the R&D team in the formation of design assurance documentation, and support the team with the current regulatory information required for new and innovative medical device designs.
- Participate in all types of design and development team reviews including leading Risk Management and FMEA activities.
- Preparing document packages for regulatory submissions and communicate with relevant regulatory authorities globally and within the EU.
- Efficient administration and management of regulatory technical documentation.
- Attend occasional off site meetings, events and consultations with a broad range of project stakeholders including medical professionals.

**Ideally you'll have**:

- Experience in Medical Device regulatory affairs.
- A degree or higher in a relevant life science, scientific or engineering-based discipline is preferable, but a combination of education and experience may be considered.
- EU 2017/745 MDR, ISO13485 & ISO14971 knowledge.
- Knowledge of MDGC, MEDDEV and MHRA guidance.
- A hands-on mentality.

This is a fantastic opportunity for a regulatory focused person to take the next step in their career, by joining an established team of experienced Engineers and developing your career long term.

Alongside a competitive salary and benefits package, is a carved out career development plan with significant scope for promotion and development for those who want it.

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