Jr RA Specialist (EU MDR), Romania in București at Stryker Corporation

Date Posted: 10/22/2020

Job Snapshot

Job Description

  • 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.
  • 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: Occasional

Travel Percentage: None

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