Banner Default Image

Regulatory Manager

Go back
  • 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:

    about 1 year 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.