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Senior Regulatory Affairs Specialist
BD
Limerick, Munster, Ireland
Full Time
On Site
Senior
EUR 56,600 – 86,300
Bachelor Degree
Healthcare
Healthcare Life Sciences
Posted 4 weeks ago
Job summary
Support regulatory activities for medical devices, ensuring compliance across product lifecycle, facilitating global market access, developing regulatory strategies, preparing documentation, and collaborating with cross-functional teams.
Responsibilities
The Senior Regulatory Affairs Specialist will provide regulatory guidance throughout the product lifecycle, ensuring compliance for infusion preparation and delivery products. They will review technical documentation, manage global product registrations, and partner with cross-functional teams to support successful market access.
Qualifications
Candidates must have a bachelor's degree in a relevant scientific or engineering discipline and proven regulatory affairs experience within the medical device industry. Proficiency in international regulatory frameworks such as EU MDR, UK MDR, and FDA requirements, along with experience in ISO 13485 environments, is essential.
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Senior Regulatory Affairs Specialist
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