Regulatory Affairs Officer

ICDS RECRUITMENT

North Dublin

Regulatory Affairs Officer - Medical Devices. North Dublin (with hybrid working in operation. This role is being offered initially as a fixed-term contract of 6 months duration, but may well be extended. Key areas of role responsibility lie within the areas of Regulatory Affairs activities for medical devices. Key Duties & Responsibilities: • Create, provide input to and execution of Regulatory Strategies related to existing and new medical device licences. • Preparing and managing international regulatory submissions in accordance with commercialisation plan. • Plan and prepare regulatory submissions for medical devices for specific target markets for new products, product changes and re-registrations as required. • Maintain registration information (license numbers, expiration dates etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability. • Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations. • Track registrations, variations and Health Authority commitments, related to company medicinal products and maintaining company regulatory databases for registrations, variations and commitments. • Obtaining information and keeping up to date on regulatory compliance and guidelines prepared by National Regulatory Agencies and Notified Bodies. • Processing queries from licensees and distributors on regulatory matters and supporting them where possible. • Performing regulatory compliance activities such as SOP revising, gap analysis, reviewing company specifications, change controls etc. • Review and approval of product labelling, promotional material. Interested applicants should have at least 4 years' regulatory experience in the pharmaceutical or medical device industry and have a life science or pharmacy degree or similar. The successful candidate will possess the following: • Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required. • Knowledge of medical device quality standards would be a distinct advantage. • International experience of registrations/variations/significant changes of Medicinal Products or Medical Devices. • Awareness or knowledge of the EU Guidelines on Good Pharmacovigilance Practices (GVP. • Excellent interpersonal skills. • An excellent level of attention to detail and accuracy. • Proven organisational and planning skills. • Strong verbal and written communication skills. • Enjoy and thrive in a fast-paced environment. • Good interpersonal skills, ability to work with others and independently. • Excellent IT skills in word processing, excel, PDF software such as Adobe, document management. • Proficiency in speaking, comprehending, reading and writing English is required.

445 days ago