Collins McNicholas

Role Summary:

Lead activities within the EU Authorised Representative function for the Vision Care business of the organisation.

 

Role Responsibilities:

  • Support all aspects of the EU Authorised Representative function in Ireland for the organisation
  • Deputise for the Regulatory Affairs Manager for all regulatory body communications
  • Provide EU Regulatory subject matter support to 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 and maintain product registrations for Vision Care products.
  • Submit Field Safety Corrective Action (FSCA) Reports and Field Safety Notices (FSN)
  • Field questions from the competent authorities regarding product performance and/or vigilance and recall on the EU market
  • Work with the legal manufacturer to provide responses to questions
  • Participate in notified body and competent authority inspections of Vision Care legal manufacturer and manufacturing sites
  • Manage the process for provision of certificates of free sale for Vision Care to support maintenance of business and/or market expansion including authentication, apostille and embassy legalisation
  • Upgrade the Authorised Representative policies, procedures etc for compliance

 

Regulate Subject Matter Expertise

  • Support key MDR work streams
  • Contribute to discussions internally and with notified body and competent authorities
  • Willingness to travel to company business 10-15% of time

 

Role Requirements:

  • Minimum bachelors’ degree in an engineering or scientific discipline or a Masters’ degree in regulatory affairs or a related discipline
  • 4-5 years’ experience in regulatory affairs

 

For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email aisling.lane@collinsmcnicholas.ie

First Name

Surname

Your Email (required)

Your mobile (required)

Preferred Collins McNicholas Office (required)

Comment / Cover Letter

Upload CV

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

5 Brilliant Benefits of Temping!

Benefits of Temporary Contracts Blog
Accepting temporary contracts can be an excellent way of earning an income. Whether you are on holidays from college or ‘in between jobs’, there are plenty of benefits to temping:   CV Regardless of how long a contract is, all jobs bring new and fresh experiences to your CV. Temping is a great way to upskill […]
Read More

Biopharma Report

biopharma biopharmaceuticals industry report
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More
  • Find a job
  • Apply
  • Get a job