Description:
This is a full-time permanent role based at our Client's operation in Ireland. The successful Candidate will be responsible for the following:
• Responsibility for structuring and managing technical files.
• Responsibility for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820
• Responsibility for product registration in Russia, Europe and other markets as appropriate.
• Responsibility for ensuring that device labelling is correct and that they meet regulatory requirements.
• Communicates country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies.
• Plans and prepares regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions.
• Maintains registration information (license numbers, expiration dates, etc.) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
• Communicates directly with the regulatory authorities to ensure product approvals are achieved in a timely manner.
• Performs translation activities as needed
Qualifications/Requirements
• Third level Qualification in life Science/Quality, at least 5 years experience in a regulated industry in a similar role is preferable.
• Verbal and written Russian
• Thorough knowledge of the EU, Russian requirements.
• Good communication and inter-personal skills.
• Proven problem-solving skills.
• Good computer skills including knowledge of Microsoft® Office.
• Proven organisational skills.
• High self-motivation.
• Willingness to travel on company business
For a full Job Spec and further information on this role please call Deirdre at +353 1 2784671or email your CV in the strictest confidence to dbolger@thornshaw.com
Key words: Regulatory, Regulatory Affairs, Registration Officer, Medical Device, Pharmaceutical, Russian, Quality Assurance, Compliance, Ireland Jobs