Regulatory Manager

Regulatory Manager
South Wales - Remote
Salary Negotiable

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 Networking

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

• 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.