Regulatory Affairs and Compliance Specialist

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.

If you have the skills and experience required and would like to be considered, apply now!