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- 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.
- 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 email@example.com