Senior Regulatory Affairs Officer

Job Details

Return to Search Jobs

What you need to know 
You will work as a Senior Regulatory Affairs Officer for our client, an established medical device company in the southeast area.

As the Senior Regulatory Affairs Officer, will lead activities within the EU Authorised Representative function for our client.

This is a permanent position.

Your new job 

Key duties & responsibilities:

  • Support all aspects of the EU Authorised Representative function in Ireland
  • Provide EU Regulatory subject matter support for key projects and activities.
  • Serve as the person responsible for regulatory compliance for the EU Authorised Representative.
  • 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 products.
  • Submit Field Safety Corrective Action 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.
  • Participate in notified body and competent authority inspections of legal manufacturer and manufacturing sites.
  • Manage the process for provision of certificates of free sale to support maintenance of business
  • Upgrade the Authorised Representative policies, procedures and work instructions for EU MDR compliance.
  • Provide advice regarding interpretation of MDD 93/42/EEC and MDR 2017/745 including associated guidance
  • Support key EU MDR work streams
  • Willingness to travel on company business approximately 10% of time.

What are we looking for? 

  • 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

Apply for this job now by sending your CV to John.

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and consent. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.

We Value Your Trust.


Please tick this box to agree that, by submitting your CV to Matrix Recruitment, you are giving explicit consent for all of the following:

  • For Matrix Recruitment to store your CV and personal details on our database in line with our Data Retention Policy,
  • For Matrix Recruitment to share your CV with prospective employers in accordance with our Privacy Policy and Data Protection Policy , and
  • For Matrix Recruitment to contact you with job alerts specific to your industry.

We take our Data Protection responsibilities very seriously. Please follow the links to review our policies and if you have any queries on Data Protection, please do not hesitate to contact us.

Yes, I would like to occasionally receive updates on career advice and employment news specific to my industry and be included in surveys for market research. Please tick if you agree.

Alternative Text

Recruitment Consultant: John O' Donnell

Job Categories:

Not the right job for you?

Don’t worry we have plenty of other jobs that you might be interested in. Click the button below to get in touch with us for a confidential chat.

Get in Touch