I highly recommend working with Natalia both if you are looking for a new role or if you are looking for potential candidates. Natalia worked with me through the recruitment process and always gave brilliant advice. She is one of the best recruiters I’ve ever had the pleasure to work with. I was delighted to receive and accept an offer at the end of the process and can’t wait to get started in my new role. Thanks Natalia!
- Published13 Mar 2023
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Role: Device Technical Regulatory Director
Our Client: Our client is an international pharmaceutical company with a workforce of more than 40,000 high calibre individuals – bringing medical care to patients across the globe. The successful candidate will join the team and help with the design, development and commercialisation of a diverse portfolio of device technology solutions.
- Maintain a real time view of medical device and combination product submissions, approvals, recalls.
- Critically review, approve, and lead strategy for global regulatory submissions for device components of all drug / biologic combination products.
- Provide regulatory leadership and planning expertise across the relevant device portfolios.
- Lead and manage a device technical regulatory team.
- Develop technical briefing documents on device development and regulatory plans.
- Responsible for company Notified Body (NB) strategy that enables cross-European market launches and post-launch maintenance.
- Degree in a pharmaceutical development (science/engineering) discipline, or equivalent.
- Knowledge of device design controls, ISO, FDA and EU/MDR requirements as applicable to device design, development and regulatory approval.
- Willingness to travel on an as-needs basis. averaging 10% of the working year.
- Proven track record of competence in leading program teams in problem solving approaches to technical regulatory issues.
**The client is happy to sponsor visas and offer a relocation package to the right candidate**
Senior Recruitment Consultant - Life Sciences
Lisa, based in our Dublin office is a Senior Recruitment Consultant and specialises in all things Quality Assurance and Regulatory Affairs. She holds a BSc in Nutraceuticals in Health and Nutrition from Technological University Dublin. Lisa has experience as a Medical Laboratory Aide and Medical Laboratory Technician. From here, Lisa moved into recruitment where she focuses on Quality and Regulatory based roles for the Pharma/Biopharma and Medical Device industries.