Regulatory Engineer (Medical Devices)

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. 

Role:

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.

Requirements:

Essential

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

Desirable

• 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 Jennifer.horgan@peglobal.net

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