RA and Compliance - Senior Manager in Newbury at Stryker Corporation

Date Posted: 7/12/2019

Job Snapshot

Job Description

Insert detaile

Main responsibilities:

  • Define the RAQA strategy for Stryker UK, including vigilance and  product registration for Stryker UK under new regulatory framework triggered by Brexit, as well as QMS transition to ISO 13485
  • Represent Stryker in local industry association as regulatory subject matter expert (pre and post market) as well as quality related matters  for medical devices, cosmetics, biocides , including complementary regulatory requirements, like environmental, wireless and telecommunications etc
  • Translate local regulatory requirements in measurable impact for Stryker business and support development of strategies to align and comply with country regulatory requirements
  • Develop and maintain country regulatory intelligence reports
  • Member of local leadership team, provide active advisory role on all country or region specific requirements and act as a business partner regarding all RA and QA matters
  • Act as integration lead or project manager for global or divisional integrations or projects
  • Participate in International forums and platforms for regulatory knowledge and exchanges such as IMDRF or ISO WGs
  • Liaise with RA, QA and PMS EMEA leads to define divisional strategy
  • Partner and provide RA and QA intelligence to divisional partners and play an active role in providing input to RAQA divisional strategy for Europe


  •  Knowledge of current and emerging issues and trends of the medical device regulatory environment.
  • Capability to react quickly to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
  • Ability to influence external regulatory stakeholders and shape the external regulatory environment.
  • Ability to influence and partner with cross-functional teams.
  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
  • Self-motivated, detail-oriented and capable of working independently.
  • Demonstrated ability in analytical reasoning and critical thinking skills.
  • Strong business acumen and ability to see the business drivers outside of Regulatory Affairs.
  • Excellent communication skills; both oral and written.
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner.
  • Demonstrated ability to contribute to a continuous learning and process improvement environment.
  • Capacity to react quickly and decisively in unexpected situations.


  • 5+ years working in Regulatory Affairs, preferably medical devices
  • Bachelor degree or equivalent qualifications – ie. RAC, TOPRA etc

d job description here.

Work From Home: No

Travel Percentage: Up to 50%

Join our talent network

Joining our talent network will enhance your job search and application process. Whether you choose to apply or just leave your information, we look forward to staying connected to you.

Join Our Team