Reg Affairs Manager
Our client, a leading medical device organisation, are looking to recruit a RA Manager. This role can be based in their plant in Cork or in Limerick. The successful candidate will work across both Regulatory and Project teams across to develop and maintain a strategic plan for the organisations sustaining product portfolio, including all global submissions, projects & activities.
The RA Manager will be responsible for developing, modifying, and executing regulatory related company guidelines and procedures. You will work alongside with other Regulatory leaders within the Division to ensure consistency in approaches across the business units.
Lead a regulatory team and help build a high trust and positive engagement work environment.
Agree objectives, provide regular feedback and manage performance to ensure implementation of regulatory plans and service.
Create training plans and co-ordinate training of Regulatory Affairs team members
The RA Manager will be responsible for assuring that the FDA regulatory requirements and any other applicable government or international standards are implemented and maintained. Take lead on responses to additional information requests from Global Regulatory Agencies. Maintaining annual licenses, registration and listing information
Co-ordinate product field action communications internally and externally. Track and report on product field action progress and completion.
Ensure the timely close out of audit actions and departmental NC/CAPAs
Co-ordinate adverse event filings, including MDR and MDV reports in accordance with applicable regulations. Ensure changes are correctly assessed through the Regulatory Assessment process and the impact of cumulative changes are assessed.
Utilize risk management process to determine potential and actual risk related to complaint events. Identify and present options for risk mitigation to decision makers
Provide strategic and technical guidance on regulatory requirements to the regulatory and operations teams when requested. Evaluating risk of and regulatory solutions to product and clinical safety issues and recommend solutions
Evaluate proposed manufacturing changes for regulatory filing strategies
Research and participate in industry working groups and committees
Lead and involve team in implementing continuous improvement projects
Education & Experience:
Bachelor Science in Engineering, Sciences or equivalent preferred
5+ years demonstrated regulatory affairs experience or equivalent
Knowledge of the Code of Federal Regulations, ISO 13485, MDD, Japanese and Canadian Regulations, Quality System Regulations (21 CFR) and other regulations related to Pre Market Clearance/Approval.
Ability to rapidly build product knowledge and understanding of highly technical and scientific regulatory activities
For further information on this Reg Affairs Manager role in Cork or Limerick please contact Nicola O’Connell on 091730022 / email@example.com
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