Senior Regulatory Affairs Specialist
COLLINS MCNICHOLAS RECRUITMENT
WATERFORD
Role Responsibilities: Support all aspects of the EU Authorised Representative function in Ireland for the business (contact lens, contact lens care solutions, eye lubricants, and contact lens cases. Deputise for the Regulatory Affairs Manager for all regulatory body communications. Provide EU Regulatory subject matter support to the Vision Care business for key projects and activities. Serve as the person responsible for regulatory compliance for the EU Authorised Representative. EU Authorised Representative: Develop and maintain a good knowledge of the Vision Care product portfolio. Verify the EU Declaration of Conformity, Technical Documentation and Conformity Assessment carried out by the legal manufacturer. Maintain the Authorised Representative registration with the Irish competent authority (HPRA) and maintain product registrations for Vision Care products. Submit Field Safety Corrective Action (FSCA) Reports and Field Safety Notices (FSN) in the EEA, Switzerland and candidate countries on behalf of the legal manufacturer. Field questions from competent authorities regarding product performance and/or vigilance and recall on the EU market. Work with the legal manufacturer to provide responses to questions from competent authorities. Participate in notified body and competent authority inspections of Vison Care legal manufacturer and manufacturing sites. Manage the process for provision of certificates of free sale for Vison Care to support maintenance of business and/or market expansion including authentication, apostille and embassy legalization. Upgrade the Authorised Representative policies, procedures and work instructions for EU MDR compliance. Regulatory Subject Matter Expertise: Provide advice regarding interpretation of MDD 93/42/EEC and MDR 2017/745 including associated guidance (e.g. MDCG guidance documents, Common Specifications etc.). Support key EU MDR work streams (e.g. economic operators, technical files, quality systems. Contribute to discussions internally and with notified body and competent authorities. Willingness to travel on company business approximately 10% of time. Role Requirements: Minimum Bachelor’s degree BS in law, medicine, pharmacy, engineering or another relevant scientific discipline. Master’s degree MS in regulatory affairs or a related discipline desirable. 4-5 years of professional experience in regulatory affairs with medical devices (MDD & MDR. For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email aisling.lane@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.
1653 days ago