Regulatory Affairs Specialist

Location:

Hybrid – Worksop (with occasional travel to Vernacare sites)

Reports to:

Regulatory Affairs Manager

At Vernacare, we’re 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
, you’ll 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 lifecycle—from development through to post-market activities.

You’ll 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.

• Support the development and implementation of regulatory strategies for new and existing products
• Ensure compliance with applicable regulations including UKCA, CE marking (EU MDR) and other international requirements where applicable
• Interpret regulatory requirements and provide clear, pragmatic guidance to the business

• Prepare, review and maintain technical files and regulatory documentation in line with regulatory expectations
• Support product registrations, submissions and regulatory approvals across relevant markets
• Ensure documentation is inspection‑ready at all times

• Provide regulatory input into new product development (NPD) and design change activities
• Support change control processes and assess regulatory impact of product or process changes
• Contribute to post‑market surveillance activities
  , including vigilance and reporting where required

• Act as a key contact for notified bodies, regulatory authorities and external partners
• Support and participate in regulatory audits and inspections
• Build strong relationships internally to ensure regulatory considerations are embedded early

• Monitor changes in regulations, standards and guidance (e.g., MDR updates, UK regulations)
• Assess impact to Vernacare’s products and processes, providing recommendations and action plans
• Contribute to the continuous improvement of regulatory systems, processes and ways of working within QARAC

We’re looking for someone who combines technical regulatory expertise with a collaborative, solutions‑focused mindset
.

• Proven experience in a Regulatory Affairs role within medical devices, healthcare or another highly regulated industry
• Strong working knowledge of EU MDR, UKCA and CE marking requirements
• Understanding of quality management systems (e.g., ISO 13485) and how regulatory and quality overlap
• Experience supporting technical documentation, submissions and audits

• Excellent attention to detail with strong documentation and technical writing skills
• Ability to interpret complex regulations and translate them into practical business guidance
• Confident stakeholder management skills, with the ability to influence across functions
• Strong organisational skills and ability to manage multiple priorities
• Proactive, adaptable, and comfortable working in a changing regulatory environment

• Be part of a purpose‑led business focused on sustainable healthcare solutions
• Work within a collaborative and supportive QARAC team
• Enjoy flexible hybrid working
• Gain exposure across multiple UK sites and functions
• 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:

• Life Insurance – 4x salary
• 25 Days Annual Leave + Bank Holidays
• Enhanced Sick Pay Scheme
• EV & Cycle to Work Salary Sacrifice Schemes
• Employee Assistance Programme – includes 24/7 GP access
• Mental Health First Aiders
• Refer a Friend Scheme – up to £1,000
• Company Pension Scheme
• Quarterly Impact Awards – up to £2,500
• Manager Recognition Awards

Be the driving force behind Vernacare’s growth and work with a company committed to sustainability and innovation.

If you’re looking for a role where your expertise will make a real impact, we’d love to hear from you.

Apply now and be part of Vernacare’s mission to create a more sustainable healthcare future.