Regulatory Affairs Manager

CPL

Galway

Regulatory Affairs Manager. 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 involve a thorough understanding of both the regulatory requirements required for the Medical Device Industry. Job Responsibilities. Responsible for supervising the day to day workload and operational issues of the regulatory affairs team. Including 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. Maintains an excellent understanding of the global medical device regulations. Actively pursues ways in which to improve the function of the Regulatory Affairs Department. Ensure compliance to 21 CFR 820, ISO 13485, MDD, MDR, MDSAP, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Provides regulatory leadership to development teams e.g. cross-functional alignment with issues of possible regulatory ramifications. Acts as a liaison with Quality, R&D, Legal, and Operations. Prepares submissions for device design changes and /or manufacturing changes. Reviews product and manufacturing changes for compliance with applicable regulations. Reviews protocols and reports to support regulatory compliance and submissions. Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body. Uses project management experience to create timelines and provide deliverables for regulatory projects. Provides guidance to management on upcoming regulatory changes (Brexit, MDR,) and the impact of those changes. Candidate Requirements. Level 8 degree (BS, BA) (technical discipline preferred. At least 5-7 years' Regulatory experience. Understanding of MDR. Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Ability to travel approximately 10%, including international. For an immediate interview please forward your CV using the apply button. Or call Megan Warr on 091507515 for a confidential conversation.

1252 days ago