Regulatory Engineer

Are you a Regulatory Engineer looking for an exciting, new challenge with a global market leading manufacturing company that can boast an excellent reputation? Does the thought of a varied role with excellent career prospects appeal to you? Do you want to be part of a forward-thinking environment where you can take advantage of excellent career development and ongoing training?

We are currently recruiting for a Regulatory Engineer based in Swansea to join a leading expert in medical technology, Salary is £28,000 - £32,000 p/a.

Regulatory Engineer Key Responsibilities:

• Prepare device samples for regulatory submissions.
• Determine regulatory artwork requirements device type plate requirements, sales box, and user instructions (regulatory markings & logos).
• Establish and maintain regulatory specific device market approval records, including MDSAP / ISO13485 / EU MDR / China NMPA auditee.
• Compile environmental data for waste regulations. WEEE licence UK & Europe.
• Manage regulatory department schedule and regulatory engineering tasks.
• Develop Critical Path Schedules (CPS) and summarize using the regulatory 'Advanced Quality Planning Process' templates.
• Support development team to compile regulatory input for the technical files for each device platform.
• Establish and maintain device platform regulatory test requirements instruction.
• Define testing requirements to comply with the latest applicable test standards.
• Provide the regulatory marking and labelling requirements for device and product artworks.
• Work directly with UK test laboratories satisfying worldwide testing requirements.

Desired Experience:

• Project management experience within electrical/electronic industry.
• Regulatory management experience within medical devices.
• Working knowledge of ISO 13485/MDSAP/MDD changing to EU MDR.

Essential Qualification:

• HNC/HND electrical/electronic Engineering.

Benefits:

• £28,000 - £32,000 per annum.
• 25 days holiday plus bank holidays.
• Pension contribution 5%.
• Career progression opportunities.
• Employee Assistance Programme.
• Monday - Friday, Days, hours negotiable.

For immediate consideration, please forward your CV to Kayleigh at Vibe Recruit today.

Vibe Recruit is acting as an Employment Agency in relation to this vacancy.

Vibe Recruit is acting as an Employment Agency in relation to this vacancy.