Senior Regulatory Affairs Specialist (CoE Medical Devices)

Pracovní nabídka

Senior Regulatory Specialist CoE (Medical Devices)

The role of Senior Regulatory Affairs Specialist is to assure regulatory support around the world. Coordinates cooperation between local/regional teams and medical device manufacturers to assure timely delivery of the regulatory documentation in line with corporate strategies and notification/submission timelines and in compliance with applicable regulations.

KEY ACTIVITIES/ RESPONSIBILITIES:

· Coordinate the regulatory activities related to new markets expansion and MOB implementation.

· Contribute to the planning and tracking of regulatory submissions across multiple regions.

· Maintain project timelines, trackers, and documentation to support efficient execution of regulatory activities.

· Collaborate with global and regional Regulatory Affairs teams to facilitate alignment on submission timelines and requirements.

· Monitor progress of regulatory deliverables and follow up with stakeholders to support timely completion of activities.

· Represent Regulatory Affairs on cross-functional technical committees.

· Identify potential risks or delays in regulatory timelines and communicate them to relevant stakeholders.

· Prepare project updates, reports, and documentation to support internal communication and governance processes.

· Contribute to continuous improvement of regulatory project coordination processes and tools.

QUALIFICATIONS:

· University degree in life science, medical science, pharmaceutical, engineering, chemistry or biotechnology.

· At least 3 years of experience in regulatory affairs, quality or compliance with Medical Devices.

· Advanced knowledge of medical device international regulations and environment.

· Strong organizational and communication skill, self-motivated, detail-oriented and capable to work independently.

· Capability to react quickly to changes in the regulatory environment.

· Precise planning and execution to achieve accurate and timely results.

· Ability to manage multiple priorities.

· Fluent in English (written and spoken).

· Advanced knowledge of MS Office.