Department Leader, Regulatory Affairs (PRRC) – IVD
Hartmann Young have partnered with a well-established and innovative developer of in vitro diagnostic products, who are looking to appoint an experienced Department Leader, Regulatory Affairs to join their growing Quality & Regulatory team in the UK.
This is an excellent opportunity for an experienced regulatory professional to lead a high-performing team, shape global regulatory strategy, and play a key role in bringing innovative diagnostic products to international markets while ensuring continued regulatory compliance across an established product portfolio.
Role:
- Lead the Regulatory Affairs function, providing strategic direction and day-to-day management of the regulatory team.
- Oversee global regulatory submissions, registrations and approvals for new and existing IVD products.
- Act as the organisation’s Person Responsible for Regulatory Compliance (PRRC), ensuring compliance with applicable medical device regulations.
- Manage regulatory activities across key markets including international territories.
- Prepare, review and maintain technical documentation and regulatory submissions in line with IVDR, FDA and other global requirements.
- Assess product changes for regulatory impact and oversee submission of change notifications where required.
- Act as the primary contact for regulatory authorities, notified bodies, customers and distribution partners on regulatory matters.
- Support the development and continuous improvement of Quality Management System processes aligned with ISO 13485 and GMP requirements.
- Provide regulatory expertise to cross-functional teams throughout the product lifecycle, from development through post-market activities.
- Lead, mentor and develop the Regulatory Affairs team while contributing to wider Quality & Regulatory strategy.
Person:
- Degree qualified in a relevant scientific discipline or equivalent regulatory qualification.
- Extensive Regulatory Affairs experience within the IVD, medical device or other highly regulated healthcare industry.
- Proven experience managing global regulatory submissions, including EU IVDR/CE marking and US FDA submissions (510(k), PMA and/or BLA).
- Strong knowledge of ISO 13485 / international medical device regulations.
- Experience acting within a regulatory leadership or people management role.
- Excellent understanding of post-market regulatory compliance and product lifecycle management.
- Strong communication and stakeholder management skills, with the ability to build relationships across technical, commercial and regulatory teams.
- Experience working with immunodiagnostic or in vitro diagnostic products would be advantageous.
- Regulatory Affairs Certification (RAC) or equivalent professional accreditation would be beneficial.
If this sounds like an opportunity of interest, please reach out or apply directly below—we’d love to hear from you!
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