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Regulatory Affairs Manager Medical Devices

Reference:AILO-100220 Location: Limerick
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Regulatory Affairs Manager Medical Devices
Our client, a global medical device organisation requires a Regulatory Affairs Manager to join their Regulatory Affairs Team on a permanent basis. The Regulatory Affairs Manager will report into the Director of Regulatory Affairs. The ideal candidate will have people management experience and experience in ISO13485.

• Supervising the day to day workload and operational issues of the regulatory affairs team which includes setting team and individual objectives, carrying out performance appraisals, generating training plans and dealing with performance related issues
• Co-ordinate the day to day running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements
• Responsible for implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required and other jurisdictions as required
• Maintain an excellent understanding of the global medical device regulations
• Actively pursues ways in which to improve the function of the Regulatory Affairs Department
• Monitor the progress of RA team members on assigned tasks, and removes roadblocks
• Work with senior management to allocate sufficient resources to complete projects in a timely manner
• Provide direction and logistical support to the RA team members to complete assigned tasks
• Foster accountability within the team to meet established timelines
• Mentor and train new RA team members
• Highlight any updates to regulatory requirements to Senior Management
• Plan and prepare regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same
• Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction
• Develops global regulatory strategies for medical devices in collaboration with other regulatory affairs or clinical personal, especially on high risk devices
• Advise other functional units such as engineering, marketing, operations, and quality, of the requirements in each target market and updates same on approval status in target markets
• Ensure the biocompatibility requirements of the product are adequately addressed
• Ensure the clinical requirements of the product are adequately addressed
• Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements
• Communicate status of projects / submissions directly to RA Management and other stakeholders as required
• Communicate directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner
• Serves as a liaison on regulatory issues between the manufacturer and the local office and or the distribution partner
• Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required
• Maintain a system for registration information (license numbers, expiration dates etc.) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability
• Provides 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 to functional units such as tenders, customer quality and distribution
• Ensure complaints are assessed for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.) and associated correspondence to applicable Regulatory bodies- designee peer review of same when required

• Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is 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 requirements in other jurisdictions where required
• 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

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

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