Senior Regulatory Affairs Specialist, UK de Newbury em Stryker Corporation

Data de Postagem: 5/30/2019

Resumo do Emprego

Descrição do Emprego

12 month fixed term contract role based in Newbury

This role will focus on pre Brexit preparation and is the ideal way for a detail orientated degree qualified professional to transition into the medical devices industry. 

Ideally suited to  someone from the legal, compliance or other regulated industry.

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This job typically requires a degree or equivalent and a minimum of 2 or more years experience.

The Regulatory Affairs Specialist UK is responsible for in country registrations under new regulations introduced following Brexit, verifying compliance of Stryker products to UK regulatory requirements and ensuring fulfilment of regulatory obligations and timely market access in the UK.  

  • Obtains product registration dossiers from international manufacturing sites, EU MDR Central Economic Operator Team and EMEA product registration team and tailor them to meet UK registration requirements where necessary.
  • Develop close collaboration and communication with international manufacturing sites, EU MDR Central Economic Operator Team and EMEA product registration team to ensure timely dossier submission and in-depth understanding of local regulatory requirements. 
  • Communicate with Stryker UK commercial teams and other relevant stakeholders to track and ensure timely dossier submission in line with business strategy.
  • Review product change requests which may impact existing or ongoing registrations and product supply in the UK.
  • Review country specific registration documentation from manufacturing sites and ensure compliance with local in country regulations.
  • Maintain UK product registration records and facilitate RA flag release for UK compliant products in relevant ERP systems to ensure timely market access. 
  • Reports UK registration metrics to RA Management, UK commercial teams and international manufacturing sites.
  • Escalates UK regulatory compliance gaps and potential patient safety issues to the EMEA RA Management and international manufacturing sites in a timely manner.
  • Communicate Brexit impact on in country registrations / market access to EMEA RA management in a timely manner and support the training of internal stakeholders in understanding registration requirements post-Brexit.
  • Provide support to the EMEA RAQA team on various activities as required.

Key requirements for the role:

  • Fluent in English.
  • Educated to university degree level (Business / Legal / Life Sciences preferred).
  • Minimum of 2 years in a regulatory role with a proven successful track record.
  • Sound knowledge of EMEA and international medical device regulatory frameworks. 
  • Understanding of EU MDR requirements preferred.
  • High attention to detail and process consciousness.
  • Versatility, flexibility and willingness to work with changing priorities.
  • Strong organisational, problem-solving and analytical skills.
  • Ability to work in a rapidly changing environment.
  • Ability to handle multiple projects and meet deadlines, working closely with RAQA Specialists and Managers across the region.
  • Strong IT skills, including Microsoft Office Suite.

Work From Home: No

Travel Percentage: None

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