Ref No: AM17849
County Dublin, Republic of Ireland
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.