Medical Device Compliance Lead
1 week ago
We're seeking a skilled Medical Device Compliance Lead to join our team at TN Ireland. As a key member of our Regulatory Affairs department, you'll play a pivotal role in ensuring compliance with global regulatory requirements and quality system regulations.
About the Job:
- This role involves providing expert support for Regulatory Affairs related issues, ensuring seamless compliance with global regulatory requirements and Quality System regulations.
- The successful candidate will be accountable for executing and completing tasks and deliverables related to CE marking activities according to the IVD Directive & Regulation.
- A significant aspect of this role will be preparing and maintaining accurate Technical Documentation for Irish manufactured products.
- You'll also be responsible for providing timely updates and maintaining the status of product registrations and notifications.
- This role demands rigorous regulatory input and approval for changes and classifications to Device Master Records, Quality System records, labelling etc.
- Maintaining the ETMS To Do training list, including relevant standards, directives, and regulations, is another critical responsibility.
About Your Qualifications:
- We're looking for a highly qualified individual with a relevant third-level qualification to degree level and a minimum of 2-3 years' experience in Regulatory, Technical or Quality areas within the devices or pharmaceutical industry.
- Advanced organizational skills and attention to detail are essential for success in this role.
- IVDR experience is desirable but not compulsory.
- Strong communication and interpersonal skills are necessary to foster effective collaboration with colleagues.
- High levels of integrity and professionalism are expected in delivering outstanding results.
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