Ref No: AM17005
County Limerick, Republic of Ireland
Regulatory Affairs Manager - County Limerick.
The primary function of this role is to supervise the Regulatory Affairs area to ensure that it runs in a smooth and efficient manner. The function will require a thorough understanding of the regulatory requirements required for the Medical Device Industry.
Responsible for supervising the day to day workload and operational issues of the regulatory affairs team. This includes, but is not limited to, 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.
Responsibility 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 pursue ways in which to improve the function of the Regulatory Affairs Department.
Monitor the progress of RA team members on assigned tasks, and remove 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 collaborate with your assigned regulatory specialists on same.
Review submissions generated for your assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
Develop global regulatory strategies in collaboration with other regulatory affairs or clinical personnel (as applicable), especially on high risk devices.
Advise other functional units (engineering, marketing, operations, quality etc.) of the requirements in each target market and update 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.
Serve as a liaison on regulatory issues between the the company and the local office and/or distribution partners.
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 obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
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.
Ensure that complaints are assessed for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.) and associated correspondence to applicable Regulatory bodies.
Act as a designee for the Director of Regulatory Affairs.