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.
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