over 1 year 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.
Project Management & Communication
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 Product Testing
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
The experience you’ll bring to the team as Regulatory Manager
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
And this is what you’ll get in return
Salary commensurate with experience
Annual Salary review
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.