RA Manager, EMEA in Amsterdam at Stryker Corporation

发布日期: 8/23/2019

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职位描述

  • Support the development of international regulatory strategies and approval pathways to ensure regulatory compliance and successful market access across Europe, Middle East and Africa.
  • Lead regional strategic regulatory projects and ensure timescales and regulatory pathways are understood and delivered.
  • Partner with the business by driving regulatory processes and activities. 

Expected deliverables according to local needs, trainings provided and experience:

  • Line management of the local RA Specialists across the EMEA region.
  • Support the preparation and coordination of registration submission planning and KPI reporting for the EMEA division in accordance with sales and marketing strategy.
  • Analyse and monitor registration activity to ensure performance is in line with objectives and communicate performance to the business.
  • Act as the franchise lead for assigned product portfolios, supporting the preparation and compilation of compliant registration dossiers to secure market access and assessing impact of product changes to registration approvals throughout the product lifecycle. 
  • Work in collaboration with EMEA Marketing teams to ensure market clearance / access issues are resolved so that new product launches are planned in line with business expectations and changes affecting market clearance are managed.
  • Ensure alignment between the EU MDR Central Economic Operator team and EMEA registration processes.
  • Subject matter expert on EMEA regulations and policies and provide advice / training to the commercial teams and international Design Divisions.
  • Act as Divisional Process Owner on EMEA projects around pre-market activities.
  • Represent Regulatory Affairs in Merger and Acquisition activity to ensure successful RA integrations across EMEA.
  • Support pre-market process improvement projects and ensure effective transposition of Corporate SOPs at divisional / local level.
  • Support international or Corporate RAQA projects.
  • Deputise for Senior RA Manager EMEA where necessary.
  • Fluent in English
  • Degree graduate (Science / Engineering / Legal / Business fields)
  • Advanced qualifications in Regulatory Affairs (RAC, MSc etc) preferred
  • Member of RAPS / TOPRA
  • Minimum of 8 years in an RAQA role with a proven successful track record.
  • Sound knowledge of EU / US / EMEA regulatory frameworks and EU MDR.
  • High level communication skills, liaising with local and EMEA management teams.
  • Well established communications with key stakeholders.
  • Proven and measurable track record on key projects within an RAQA environment.
  • Capable of leading projects autonomously (problem solving oriented) with minimal supervision. 
  • Work to strict deadlines and under pressure. 
  • Line management experience preferred.

Work From Home: No

Travel Percentage: Up to 25%

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