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Details

Regulatory Affairs Specialist


Reference:AKPI-641484 Location: Limerick
Qualification:DegreeExperience:4-5 Years
Job Type:Temporary ContractSalary: Not Disclosed

Regulatory Affairs Specialist
Our client, a global medical device organisation requires a Regulatory Affairs Specialist to join their Regulatory Affairs Team. 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 high risk devices
• Advise other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market
• Ensure the outputs from the individual functional units meet the applicable regulatory requirements
• Plan and prepare regulatory submissions for specific target markets for new products, product changes and re-registrations as required
• Maintain registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability
• Ensure the biocompatibility requirements of the product are adequately addressed
• Communicate the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed
• Communicate directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required
• Act as a liaison between the manufacturer and the International local office and or distribution partner on regulatory issues
• Provide support to currently marketed products as necessary including input on change requests, etc
• Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations
• Provide regulatory support functional units such tenders, customer quality and distribution

Requirements
• Third level Qualification preferably in Science/Engineering; 5 years ‘experience in a regulated industry in a similar role desirable
• Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required
• Knowledge of medical device quality standards/practises or similar regulated industry
• Knowledge of medical device quality standards/practises or similar regulated industry
• Good communication and inter-personal skills
• Proven problem-solving skills
• Good computer skills including knowledge of Microsoft Office
• Proven organisational skills
• High self-motivation
• Approved External Auditor
• Willingness and availabilityto travel on company business






If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252