Senior Regulatory Specialist, EMEA Regulatory Affairs (Clinical Investigation Support)

Senior Regulatory Specialist, EMEA Regulatory Affairs (Clinical Investigation Support)

Boston Scientific

Prague, Athens or Warsaw

This is a key role supporting clinical investigations in the EMEA region for the entire Boston Scientific product portfolio, reporting to the responsible Manager. Within the EMEA Regulatory Affairs organization, the main objectives of the role will be to contribute to successful business goals by supporting regulatory activities linked to pre- and post-market clinical investigations, as well as all associated safety reporting in the EMEA region.

Key Responsibilities:

  • As a Senior Regulatory Affairs Specialist, you will partner with global cross-functional teams to provide input on requirements, strategies and documentation needed to obtain regulatory approval for clinical investigations in EMEA;
  • You will prepare and submit the application files for clinical investigation to Competent Authorities;
  • You will maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed;
  • You will participate in team meetings with colleagues based in the US, EU, and other regions teams contributing to and learning from global clinical investigation submission and strategy experiences;
  • You will support analysing and optimizing RA processes together with cross functional partners such as Quality Management, Clinical Affairs and Medical Safety in order to improve procedures or integrate new and changing regulations;
  • You will also support the Regulatory Affairs team and other functions with internal and external audits;
  • Advocacy/monitoring new regulations.

Required Qualifications:

  • You have completed BS in Engineering, Science, or related degree, or MS in Regulatory Science;
  • You have gained a minimum of 4 years’ experience in medical technology or another regulated sector in the area of quality, regulatory affairs or R&D;
  • You have already acquired a working knowledge of ISO 14155, EU MDR 2017/745, MDCG 2021-6 and 2020-10/1, and other national or global regulations related to clinical investigations;
  • You have strong time management, coordination, and communication skills, capable of independently execute regulatory tasks& relevant administrative activities and demonstrating a proactive approach to work within a dynamic regulatory environment;
  • Your English language skills enable you to collaborate with colleagues as well as internal and external stakeholders on a global basis. Additional language skills are an advantage.

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