Science & Pharmaceutical JobsSenior Regulatory Affairs Specialist

  • CJ49686
  • Permanent
  • Tipperary, Waterford

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Collins McNicholas

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

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