At Vernacare, were committed to protecting people and the planet through innovative, sustainable healthcare solutions. As a Regulatory Affairs Specialist within our
QARAC (Quality, Assurance, Regulatory Affairs & Compliance) team, youll play a critical role in ensuring our products meet the highest regulatory standards while supporting innovation and growth across our portfolio.
This is a key position within the QARAC team, responsible for supporting regulatory compliance across the full product lifecyclefrom development through to post-market activities.
Youll act as a subject matter expert on regulatory requirements, working closely with colleagues across R&D, Quality, Manufacturing and Commercial teams to ensure that products are compliant, competitive, and aligned to evolving regulatory frameworks.
This is a hybrid role, with flexibility built in, alongside occasional travel to Vernacare sites across the UK to support collaboration, audits and project activity.
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Support the development and implementation of regulatory strategies for new and existing products
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Ensure compliance with applicable regulations including UKCA, CE marking (EU MDR) and other international requirements where applicable
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Interpret regulatory requirements and provide clear, pragmatic guidance to the business
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Prepare, review and maintain technical files and regulatory documentation in line with regulatory expectations
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Support product registrations, submissions and regulatory approvals across relevant markets
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Ensure documentation is inspection-ready at all times
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Provide regulatory input into new product development (NPD) and design change activities
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Support change control processes and assess regulatory impact of product or process changes
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Contribute to post-market surveillance activities, including vigilance and reporting where required
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Act as a key contact for notified bodies, regulatory authorities and external partners
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Support and participate in regulatory audits and inspections
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Build strong relationships internally to ensure regulatory considerations are embedded early
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Monitor changes in regulations, standards and guidance (e.g., MDR updates, UK regulations)
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Assess impact to Vernacares products and processes, providing recommendations and action plans
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Contribute to the continuous improvement of regulatory systems, processes and ways of working within QARAC
Were looking for someone who combines technical regulatory expertise with a collaborative, solutions-focused mindset.
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Proven experience in a Regulatory Affairs role within medical devices, healthcare or another highly regulated industry
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Strong working knowledge of EU MDR, UKCA and CE marking requirements
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Understanding of quality management systems (e.g., ISO 13485) and how regulatory and quality overlap
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Experience supporting technical documentation, submissions and audits
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Excellent attention to detail with strong documentation and technical writing skills
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Ability to interpret complex regulations and translate them into practical business guidance
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Confident stakeholder management skills, with the ability to influence across functions
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Strong organisational skills and ability to manage multiple priorities
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Proactive, adaptable, and comfortable working in a changing regulatory environment
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Be part of a purpose-led business focused on sustainable healthcare solutions
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Work within a collaborative and supportive QARAC team
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Enjoy flexible hybrid working
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Gain exposure across multiple UK sites and functions
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Be part of a company that values innovation and continuous improvement
We offer a competitive benefits package designed to support your wellbeing and reward your contributions:
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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 includes 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
Be the driving force behind Vernacares growth and work with a company committed to sustainability and innovation.
If youre looking for a role where your expertise will make a real impact, wed love to hear from you.
Apply now and be part of Vernacares mission to create a more sustainable healthcare future.
