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Jr RA Specialist, Italy (EU MDR) - Roma - Stryker Corporation

Date de publication : 6/1/2019

Résumé de l'offre

Description de l'offre

The Jr Regulatory Affairs Specialist (EU MDR) is responsible for in country re-registrations under Stryker’s EU MDR transition programme, verifying compliance to the EU MDR for Stryker products, ensuring fulfilment of regulatory obligations and timely market access in EU countries or countries that rely on CE marking for product registration purposes.

  • Obtains product registration dossiers from international manufacturing sites / EU MDR Central Economic Operator Team and tailor them to meet country registration requirements.
  • Develop close collaboration and communication with international manufacturing sites / EU MDR Central Economic Operator Team to ensure timely dossier submission and in-depth understanding of local regulatory requirements. 
  • Communicate with Stryker consultants and distributors to track and ensure timely dossier submission.
  • Review product change requests related to EU MDR which may impact existing or ongoing registrations and product supply.
  • Review country specific registration documentation from manufacturing sites and ensure compliance with local in country regulations.
  • Maintain EU MDR product registration records and facilitate RA flag release for EU MDR compliant products in relevant ERP systems to ensure timely market access. 
  • Reports registration metrics to RAQA management and works with the EMEA RA team to plan and deliver documentation reviews to specified timeframes.
  • Escalates EU MDR regulatory compliance gaps and potential patient safety issues to the EMEA RA Management and international manufacturing sites in a timely manner.
  • Communicate EU MDR related impact on in country registrations / market access to EMEA RA management in timely manner.

Key requirements for the role:

  • Fluent in English and Italian.
  • Educated to university degree level (Business / Legal / Life Sciences preferred).
  • Experience in a medical device regulatory role preferable.
  • Sound understanding of EU MDR requirements and obligations preferable.
  • 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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