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RA and Compliance - Senior Manager in Newbury at Stryker Corporation

发布日期: 6/12/2019

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职位描述

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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

Requirements:

  •  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.

Experience:

  • 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%

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