Regulatory Affairs Manager (Medical Devices)

CareerWise Recruitment

Galway

A Regulatory Affairs Manager is required by CareerWise Recruitment for our Galway based Medical Devices client. The primary function of THhe Regulatory Affairs Manager 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. The role will report directly to Snr Manager of Regulatory Affairs. Please contact Tom Devaney for more information. THE ROLE: * 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. * 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. 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. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1250 days ago