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Regulatory Affairs Manager -MDR

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Job Description


Johnson and Johnson are using our breadth, scale and experience to reimagine the way healthcare is delivered and help people live longer healthier lives.

In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopaedics, vision and interventional solutions with the big ideas of others to design and deliver physician and patient-centric products and solutions.

As pioneers in medical devices, we continually focus on elevating the standard of care—working to expand patient access, improve outcomes, reduce health system costs and drive value. We build smart, people-centred healthcare to help the patients we serve to recover faster and live longer and more vibrantly.

The Regulatory Affairs Manager-Medical Device Reporting coordinates the execution and strategic elements of the implementation of EU MDR requirements across DePuy Synthes. The RA Manager directs and coordinates activities concerned with the Notified Bodies including the scheduling of audits/reviews, coordinating face-to-face meetings, and resolving corrections. This person will act as a Subject Matter Expert on new guidance documents and MDR updates that have a bearing on the implementation of MDR. The EU MDR lead will provide guidance and execution support to project team members regarding regulatory compliance issues and potentially help prepare and maintain regulatory submissions and files.

You will also maintain the prioritization of submissions to the Notified Bodies and act as an internal liaison to ensure that DePuy Synthes presents itself in a harmonized manner to our external customers. Ensures adherence to standard operating procedures and protocol for the rapid and timely implementation of EU MDR across DePuy Synthes.


Qualifications
  •  The successful applicant will have a demonstrated track record of success in regulatory project management and will have experience with the EU Medical Device Regulations. 
  • You will have an advanced degree in medical sciences or related field.
  • Direct author and/or support of regulatory submissions in the UK and Europe.
  • Knowledge of EU submissions including familiarity with MDD/MDR is required.
  • The previous functional experience that is technically or scientifically related (i.e. quality, medical, clinical and R&D).
  • Experience of developing and executing global strategies that align with business deliverables is preferred.

The primary location for this role is Leeds UK; however,  secondary locations in the EU and US is possible for the right candidate.


This position could involve 10-20% travel.

 

 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Primary Location
United Kingdom-England-Leeds-
Organization
DePuy UK Holdings Limited (8721)
Job Function
Regulatory Affairs
Requisition ID
00001FGS