Regulatory Compliance & Standards Officer

My client are a medical device organisation and are seeking to take on a Regulatory Compliance and Standards Officer on a permanent basis. They're located in Waterford. They have a reputation for introducing and marketing innovative, high-quality products. They currently employ over 1000 people, and you could be the next to join them!

What will be doing as a Regulatory Compliance and Standards Officer?

  • The Compliance & Standards Officer is responsible for compliance as required by 2017/745 MDR, lead standards compliance programs and product registration alignment activities.
  • Standards management process
  • ISO13485 & MDSAP compliance.
  • Project Management
  • SME supporting EU MDR implementation.
  • Verification of product specification content in product registration.
  • Set up and maintenance of a process for PRRC as per article 15 of MDR.
  • Manage standards compliance and drive harmonisation for CL sites ensuring sites have up-to-date standards lists in place.
  • Manage communication between competent authorised and/or notified bodies in regards to product performance and/or vigilance on EU market and forward all correspondence to the legal manufacturer.
  • Conduct review and verification assessments of product registrations and/or renewals
  • Support projects as assigned EU MDR etc ensure risks are identified, assessed and mitigated.
  • Support audits and inspections of manufacturers, importers and distributers.
  • Co-ordinate and participate in standards group e.g.ISO
  • Participate in local activities in Irelands e.g. HPRA< NSAI, IMDA meetings.

What I need to be a Regulatory Compliance and Standards Officer?

  • 3rd level qualification in Quality, Regulatory, Engineering or another relevant scientific discipline.
  • At least 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

If you think the position in Waterford is the step in the right direction for you and have experience in a similar role, don't hesitate in applying. If you think you might be interested in becoming a Regulatory Compliance and Standards Officer and looking for more information, I will contact you upon application and discuss this further with you! Please note sponsorship is not offered with this role.

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