Regulatory Affairs Manager Role

Vor 4 Tagen


Burgenland, Österreich Life Science Recruitment Vollzeit

Benefits:

This is a great opportunity to join a dynamic team in a rapidly growing company. Our client offers a competitive salary package, bonus structure, pension scheme, healthcare benefits, and hybrid working arrangements. You will also have the opportunity to work on challenging projects and develop your skills and knowledge.

Job Description:

The Senior Regulatory Affairs Specialist will be responsible for implementing post-market activities, approving Vigilance/MDR reporting, and supporting Regulatory Post Market System improvements. The ideal candidate will have a strong understanding of regulatory requirements and experience in implementing post-market strategies.

Responsibilities:

  • Develop and implement post-market strategies to ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams to ensure successful implementation of Field Safety Corrective Action plan and associated activities.
  • Lead Regulatory Post Market System improvements to enhance efficiency and effectiveness.
  • Provide technical expertise to design teams for Key Projects identified by Veryan.
  • Manage and support trend data for regulatory reporting and PMA Annual Periodic Reporting system.

Requirements:

  • A degree-level qualification in Engineering, Science, QA, or related field is essential.
  • A minimum of five years' experience at a senior regulatory level in the medical device industry is essential.
  • A minimum of five years' experience in the creation of regulatory submissions for premarket approval is required.
  • Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.


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