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Regulatory Manager

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  • Location:

    Cardiff

  • Sector:

    Engineering & Technical

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Phil Pitman

  • Email:

    ppitman@yolkrecruitment.com

  • Contact phone:

    02921 673717

  • Job ref:

    BH-26535

  • Published:

    14 days ago

  • Expiry date:

    15 February 2049

  • Start date:

    2021-09-30

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.