Regulatory Engineer

Regulatory Engineer

£30,000 + great benefits

Swansea onsite

Full time permanent

Are you a Regulatory Engineer looking for a new, exciting role for a fast-growing company offering opportunities of progression? Have you got a Project management experience within Electrical/Electronic industry?

Please read on!

Vibe Recruit is now seeking a Regulatory Engineer to join one of our very successful clients based in a convenient location in Swansea.

The main purpose of this role is to obtain and maintain all country specific regulatory clearances for client devices to comply with the individual country regulations.

Key Responsibilities:

· Broad worldwide knowledge Medical Device status

· Determining country specific MD requirements for submissions, including US, Canada, China, South Korea, EU MRD classifications

· Annual MD Registrations for each MD territory.

· Maintain global regulatory certifications for existing device lines.

· Notified changes, change control to Notified Bodies (NB's).

· Legalization of documents for regulatory submissions.

· Preparing device samples for regulatory submissions.

· Determining regulatory artwork requirements device type plate requirements, sales box and user instructions (regulatory markings & logos).

· Establishment and maintenance of regulatory specific device market approval records, including MDSAP / ISO13485 / EU MDR / China NMPA auditee.

· Comply with Regulatory procedures, including MD country specific procedures.

Project Management & Communication

· Manage regulatory department schedule and regulatory engineering tasks.

· Develop Critical Path Schedules (CPS) and summarize using the regulatory 'Advanced Quality Planning Process' (APQP) templates.

· Supporting Development team to compile regulatory input for the Technical Files for each device platform.

· Ability to run regulatory requirement project meetings with Development team, overseas consultants and customers

Regulatory Product Testing (Outputs)

What are we looking for in you?

· Project management experience within Electrical/Electronic industry

· Regulatory management experience within medical devices

· Working knowledge of ISO 13485/MDSAP/MDD changing to EU MDR

· HNC/HND Electrical/Electronic Engineering or degree in a relevant scientific discipline, or related experience

· Excellent written and verbal communication skills

· Excellent accuracy and attention to detail

· Capable of working on multiple projects, both independently and in a team environment

· Able to critically evaluate and summarise complex data into simple messages and actions

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