Regulatory Affairs Specialist

Job Listing No: 9740000

Regulatory Affairs Specialist

Limerick – Our client, a global medical device organisation requires a Regulatory Affairs Specialist to join their Regulatory Affairs Team on a permanent basis. Regulatory Affairs Specialist Our client, a global medical device organisation requires a Regulatory Affairs Specialist to join their Regulatory Affairs Team on a permanent basis. The Regulatory Affairs Specialist will report directly into the Regulatory Affairs Manager. Responsibilities Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required Ensure a thorough understanding of the products they are assigned Communicates country & region specific regulatory requirements to the regulatory specialists & managers Develop global regulatory strategies for medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on … – Permanent – Full-time

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