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Regulatory Affairs Specialist (Worksop)

Vernacare International Ltd
Worksop

Quick apply

Job details

Benefits

Cycle to work scheme
Annual leave
Company pension
Employee assistance programme
Life insurance
Referral programme
Sick pay

Qualifications

Quality management
Organisational skills
Technical writing

Full job description

Regulatory Affairs Specialist

Location: Hybrid Worksop (with occasional travel to Vernacare sites)

Reports to: Regulatory Affairs Manager

Join Vernacare and help shape the future of sustainable healthcare

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.

The Opportunity:

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.

What Youll Be Doing:

Regulatory Compliance & Strategy

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

Technical Documentation & Submissions

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

Product Lifecycle Management

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

Stakeholder & Authority Interaction

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

Regulatory Intelligence & Continuous Improvement

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

What Were Looking For:

Were looking for someone who combines technical regulatory expertise with a collaborative, solutions-focused mindset.

Experience & Knowledge

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

Skills & Attributes

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

Why Join Vernacare?

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 Vernacares growth and work with a company committed to sustainability and innovation.

Interested?

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.

Quick apply

Refine Your Search

regulatory affairs manager jobs in wingerworth, dby

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