Engineering & Electronics

Regulatory Engineer (Medical Devices)

  • Full Time
  • Wales
  • 41975243

PE Global is currently recruiting for a Regulatory Engineer for a leading multi-national medical device client based in Swansea.

This is a permanent full-time position and is 100% site based.  


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


Core Regulatory Tasks & Submissions

  • Broad worldwide knowledge IPL Medical Device status –MD submission and clearance records.
  • Determining country specific MD requirements for submissions.
  • US – FDA classification, submission, registration & GUDID.
  • Health Canada classification, submission & registration.
  • South Korea classification, submission & registration.
  • EU MDR classification, submission, registration and EUDAMED.
  • China NMPA classification, submission, registration and database.
  • Annual MD Registrations for each MD territory.
  • Maintain global regulatory certifications for existing device lines.
  • Notified changes, change control to Notified Bodies (NBs).
  • 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 the company’s regulatory procedures, including MD country specific procedures.
  • Review and approval artworks (sales box, IFU, type plate).
  • Review and approval of the company’s Customer Requirements Form (CRF).
  • Compiling environmental data for waste regulations. WEEE licence UK & Europe.

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 the company’s regulatory requirement project meetings with Development team. Typically weekly.
  • Ability to run the company’s regulatory requirement project meetings with the company’s customers. Typically, weekly.
  • Ability to run the company’s regulatory requirement project meetings with overseas consultants.
  • Support the company ‘Go To Market’ (GTM) project meetings for new platform launches.
  • Regulatory Networking. Outward facing industry learnings.

Regulatory Product Testing (Outputs)

  • 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.  
  • CB Submission.
  • EMC Submission.
  • MET and other non-MD submissions.
  • Working directly with UK test laboratories (contact/quote/budget/schedule).
  • Satisfying worldwide testing requirements (contact/quote/budget/schedule).
  • Declaration of Conformity (DOC): UK, EU, Aus, US(FCC), Hong Kong etc.



  • Project management experience within Electrical/Electronic industry
  • HNC/HND Electrical/Electronic Engineering


  • Regulatory management experience within medical devices
  • Working knowledge of ISO 13485/MDSAP/MDD changing to EU MDR
  • A degree in a relevant scientific discipline, or equivalent experience

Other attributes:

  • 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
  • Prepared to build networks and alliances with peers and external partners
  • Efficient, well organised with a systematic and methodical approach to work
  • Positive and motivated attitude

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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