Regulatory Affairs Manager (Post-Market) - FTC
Location: Chorley, Remote (UK)
Contract: Full-Time, Fixed-Term Contract for 18 Months
Company: Vernacare
Protecting Patient Safety. Supporting Global Growth.
At Vernacare, we are proud to protect the safety and dignity of patients and healthcare professionals around the world. As pioneers in sustainable healthcare solutions, we combine innovation, quality and customer focus to deliver products that make a real difference.
We're looking for a highly organised and commercially aware Regulatory Affairs Manager (Post-Market) to lead our international product registration and notification activities across key global markets. This is an exciting opportunity to join a growing business where regulatory excellence directly supports market access, revenue growth and customer success.
About the Role
As Regulatory Affairs Manager (Post-Market), you will take ownership of Vernacare's international post-market registration and notification programme, ensuring medical devices remain compliant and accessible across established and emerging markets.
Working closely with Regulatory Affairs, International Sales & Marketing, Finance and external regulatory partners, you will manage registrations, notifications and regulatory submissions across Europe, Australia, Saudi Arabia and other strategically important territories.
This is a pivotal role supporting Vernacare's international growth strategy and helping to build a sustainable, scalable regulatory framework for the future.
Key Responsibilities
- Lead the end-to-end management of international post-market registrations and notifications.
- Secure and maintain registrations across EU, EEA and priority international markets.
- Manage product registrations within EUDAMED and country-specific regulatory systems.
- Coordinate tender-driven regulatory submissions to critical commercial deadlines.
- Prepare, compile and submit registration dossiers and supporting documentation.
- Manage authorised representative, importer and distributor regulatory agreements.
- Conduct regulatory gap analyses and assess language and labelling requirements.
- Maintain a centralised register of registrations, approvals, renewals and country requirements.
- Monitor regulatory developments and communicate potential business impacts.
- Track KPIs, submission progress and regulatory risks, providing regular updates to leadership.
- Support distributors, authorised representatives and regulatory authorities with post-market regulatory activities and enquiries.
About You
You'll be an experienced Regulatory Affairs professional who thrives in a fast-paced environment and enjoys balancing technical compliance requirements with commercial priorities.
Essential Requirements
- Degree in Life Sciences, Engineering, Regulatory Affairs or a related discipline, or equivalent industry experience.
- Proven experience managing international medical device registrations and post-market regulatory activities.
- Strong knowledge of EU MDR 2017/745 and international regulatory pathways.
- Experience preparing and submitting regulatory dossiers.
- Excellent project management and stakeholder management skills.
- Ability to manage multiple concurrent submissions and deadlines.
- Strong attention to detail and commitment to regulatory compliance.
- Proficiency in Microsoft Office applications.
- Fluent written and spoken English.
Desirable Experience
- Experience with TGA (Australia) and SFDA/NUPCO (Saudi Arabia) registrations.
- Knowledge of EUDAMED registration processes.
- Experience managing registrations in European local-registration markets such as Spain, Italy or Poland.
- Understanding of GCC, MENA or APAC regulatory pathways.
- TOPRA membership or relevant Regulatory Affairs certification.
- Additional European language skills.
Why Join Vernacare?
This role supports our mission to protect the safety and dignity of patients and healthcare professionals, and contributes to our commitment to sustainable manufacturing and a resilient UK supply chain. Our organisation is built on strong values, including customer focus, accountability, recognition, and environmental and social wellbeing.
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
What You'll Gain
- A highly visible role supporting international business growth.
- Opportunity to work across multiple global regulatory markets.
- Remote working flexibility.
- Exposure to senior stakeholders and strategic projects.
- The chance to shape and improve regulatory processes within a growing healthcare organisation.
- Potential for a permanent opportunity subject to business requirements.
Interested?
If you're an experienced Regulatory Affairs professional with a passion for global compliance and market access, we'd love to hear from you.
Apply today to help Vernacare continue delivering innovative healthcare solutions to customers around the world.
Regulatory Affairs Manager (Post-Market) - Remote - FTC in Chorley employer: Vernacare International
Vernacare is an exceptional employer that prioritises the wellbeing of its employees while fostering a culture of innovation and accountability. With a hybrid working model based in Chorley or Bolton, we offer a supportive environment where you can thrive, alongside competitive benefits such as enhanced sick pay, life insurance, and opportunities for professional growth. Join us to be part of a dynamic team dedicated to making a meaningful impact in the healthcare sector.
