Location: Chorley, Lancashire - Remote/ Hybrid
Reporting to: Director of QA, Regulatory Affairs & Clinical
At Vernacare, we proudly protect the safety and dignity of patients and the healthcare professionals who care for them. As pioneers in sustainable manufacturing and healthcare innovation, we are committed to delivering exceptional product quality, outstanding customer service, and meaningful environmental impact.
We are now seeking an experienced Head of Regulatory Affairs to lead our Regulatory Affairs function and drive regulatory excellence across our diverse portfolio of Medical Devices, Veterinary Pharmaceuticals, PPE, Biocides, Cosmetics, and General Products.
This is a senior leadership role offering the chance to shape and implement regulatory strategy across a growing international business. Reporting directly to the Director of QA, Regulatory Affairs & Clinical, you will lead a team of Regulatory Affairs professionals while remaining hands-on in the delivery of key regulatory programmes and submissions.
You will play a critical role in ensuring ongoing regulatory compliance, driving market access activities, leading major projects such as MDR remediation and MDSAP readiness, and building a high-performing regulatory team that supports Vernacare's continued growth.
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Lead and develop the Regulatory Affairs and Post-Market Registration teams.
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Implement regulatory strategy and translate business objectives into practical regulatory plans.
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Drive delivery of key regulatory programmes, including MDR remediation and MDSAP certification readiness.
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Oversee global product registrations, renewals, variations, and post-market maintenance activities.
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Ensure compliance across Medical Devices, Veterinary Pharmaceuticals, PPE, Biocides, Cosmetics, and General Products.
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Collaborate closely with Quality, Clinical, Commercial, Product Development, and Operations teams.
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Manage relationships with Notified Bodies, Competent Authorities, and regulatory agencies.
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Provide expert regulatory guidance on product development, market expansion, acquisitions, and change programmes.
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Lead audit and inspection readiness activities across the organisation.
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Monitor emerging regulatory requirements and assess business impacts.
We're looking for a confident and pragmatic regulatory leader who thrives in a fast-paced regulated environment.
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Significant Regulatory Affairs experience within a regulated industry.
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Experience leading Regulatory Affairs professionals and cross-functional teams.
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Strong knowledge of EU MDR, UK MDR, ISO 13485 and technical documentation requirements.
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Proven success delivering regulatory strategies and complex regulatory programmes.
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Experience working with Quality Management Systems, audits, and regulatory inspections.
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Strong stakeholder management and communication skills.
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Ability to balance strategic leadership with hands-on regulatory delivery.
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Degree in Life Sciences, Pharmacy, Regulatory Affairs, Veterinary Medicine, Biomedical Sciences, Engineering, or a related discipline (or equivalent experience).
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Postgraduate qualification in Regulatory Affairs or related subject.
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Membership of TOPRA, RAPS, or similar professional body.
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Experience with MDSAP certification.
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Exposure to FDA, Health Canada, TGA, Veterinary Pharmaceuticals, PPE, Biocides, Cosmetics, or international registrations.
We offer a competitive benefits package designed to support your wellbeing and recognise your contribution:
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Life Insurance 4x salary
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25 Days Annual Leave + Bank Holidays
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Enhanced Sick Pay Scheme
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EV & Cycle to Work Salary Sacrifice Schemes
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Employee Assistance Programme including 24/7 GP access
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Mental Health First Aiders
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Refer a Friend Scheme up to £1,000
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Company Pension Scheme
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Quarterly Impact Awards up to £2,500
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Manager Recognition Awards
This is an outstanding opportunity for an ambitious regulatory leader to make a significant impact within a business committed to quality, innovation, sustainability, and patient care.
If you're ready to lead regulatory excellence and play a key role in shaping the future of Vernacare's product portfolio, we'd love to hear from you.
Apply today and help us protect the safety and dignity of patients worldwide.
