14 days ago
15 February 2049
South Wales - Remote
Yolk Engineering has been retained by this leading global medical device business in the recruitment of a Regulatory Manager, a post that comes with a high potential career development pathway.
The Regulatory Manager will lead a team in obtaining and maintaining all country specific regulatory clearances for medical devices to be traded and to comply with individual country regulations.
You'll be responsible for:
Core Regulatory Tasks & Submissions
- Developing a broad worldwide knowledge of relevant Medical Device status
- Determining country specific MD requirements for submissions
- Medical Device registration budgets
- Maintain global regulatory certifications for existing device lines
- Notified changes, change control to Notified Bodies (NB’s)
- Determining regulatory artwork, user instructions, and regulatory markings
- Establishment and maintenance of regulatory specific device market approval records, including MDSAP / ISO13485 / EU MDR / China NMPA auditee
- Owning Regulatory procedures, including MD country specific procedures
- Review and approval of Customer Requirements Forms
- Complying with environmental waste regulations.
- Manage the regulatory department schedule and regulatory engineering tasks
- Develop Critical Path Schedules (CPS) and summarize using appropriate tools
- Supporting Development team to compile regulatory input for the Technical Files for each device platform
- Run regulatory requirement project meetings with Development team, Customers and Overseas Consultants
- Support ‘Go To Market’ project meetings for new product launches
- Regulatory Networking
- Establish and maintain device regulatory test requirements instruction. Define testing requirements to comply with the latest applicable test standards
- CB, EMD, MET and other non MD submissions
- Working directly with UK test laboratories
- Satisfying worldwide testing requirements
- Declaration of Conformity: UK, EU, Aus, US(FCC), Hong Kong, Russia
- Regulatory management experience within medical devices
- Working knowledge of ISO13485/MDSAP/MDD/EU MDR.
- An education in a relevant scientific/technical discipline, or equivalent experience
- Salary commensurate with experience
- Annual Salary review
- Company Bonus
- Ongoing professional development
- Career development opportunities - Director pathway
- Competitive holiday/pension package
Are you up to the challenge?
If you feel you have the skills, experience and passion to be successful in the role of Regulatory Manager, apply now.