Technical Regulatory Specialist for Medical Devices
18 hours ago
This position requires a subject matter expert in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory compliance.
The successful candidate will maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to Viatris development programs.
Responsibilities include actively collaborating with the Technical Regulatory function and wider GDD on the development of regulatory strategies for combination products and medical devices.
Key duties also include leading project teams in their awareness of current regulatory best practice when building device development plans and providing mentoring for, and support the development of, the Technical Regulatory team.
The ideal candidate will provide expert advice to the EU regulatory function in relation to the device constituent of Drug Device Combination products in accordance with the Medical Device Regulation (MDR) and associated European Medicines Agency (EMA) guidelines.
They will drive the authoring and review of documents for regulatory submissions; including New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), Marketing Authorisation Applications (MAAs), variations and other related activities.
Requirements include a Bachelor's degree in a scientific/engineering discipline and proven experience in pharmaceutical and/or medical device development.
The candidate should have advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements and quality requirements.
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