Salary: £40,000 per annum
Contract: Permanent
Hours: Full time, 37.5 hours per week
Shifts: Monday to Friday, 08:30 – 17:00
Location: CareCo HQ, Braintree - CM77 7AT
Closing date: Friday 19th of June 2026
At CareCo, we make every day easier for people. As the UK's leading mobility retailer, our goal is to make sure that everybody who needs a helping hand not only gets one, but that they get the one that works for them.
About the Role
CareCo is seeking a solution based, analytical, and detail‑focused Product Compliance Specialist to support the Quality & Compliance Team.
As a Product Compliance Specialist, you will conduct expert compliance reviews of all new products, as well as technical file reviews of legacy products, ensuring conformity with applicable test standards, within the scope of Medical Device Regulations specifically. You will also be responsible for overseeing regulatory obligations in both EU and UK in line with the Medical Device Regulations.
As a Product Compliance Specialist, you will:
- Review supplier compliance evidence (e.g. test reports, Declarations of Conformity) for all new products, to ensure applicable ISO standards and UK / EU regulatory guidelines are adhered to.
- Consideration of additional global regulations as applicable.
- Advise on specific test standards and requirements as appropriate, including laboratory communication.
- Establish compliance requirements for new product categories.
- Maintain, update and manage compliance-related documentation for all products, in particular the technical files for medical device products.
- Conduct technical file reviews of legacy products to ensure continued compliance, including labelling and packaging, in line with current legislation.
- To ensure that product approval is aligned with the company’s supplier management process and the scope of a factory’s capabilities and certification.
- Maintain, monitor and report on the compliance status of the product portfolio.
- Produce Medical Device risk assessments on physical samples and advise the business of risk mitigations as an outcome.
- Develop Clinical Evaluation Plans for new and legacy products.
- Ensure that the company’s regulatory registration obligations are met (EUDAMED / MHRA)
- Assist in the arrangements of any Field Safety Notifications and/or product recalls.
- Support with Post Market Surveillance.
- Monitor evolving medical device regulations, guidance documents, standards, and industry trends, assessing their impact on existing products and communicate these accordingly.
- Support device classification and regulatory strategy activities.
- Support with responses to government and industry-related consultations – authorities such as BHTA, MHRA and Trading Standard Institute.
- Adhere to and implement all other consumer-related law such as; DVLA requirements, Sale of Goods Act, Consumer Contract Regulations, Consumer Credit Act, Consumer Protection from Unfair Trading Regulations, Consumer Rights Act, General Data Protection Regulations.
- Participate in the maintenance of the following accreditations: ISO 9001, ISO 14001, ISO 45001 and ISO 13485.
- Support the Quality & Compliance Manager with ad-hoc product compliance related tasks as required.
About you
- To be considered for the position of Product Compliance Specialist you will have:
- Demonstrable working knowledge of EU and UK Medical Device Regulations.
- An understanding of ISO management systems, including but not limited to ISO 9001, ISO 45001, ISO 14001 and ISO 13485.
- Experience producing medical device risk analysis.
- Proven experience in a product conformity environment.
- In-depth knowledge of regulatory reporting and product registration (EUDAMED, MHRA)
- Post Market Surveillance reporting.
- An understanding of electrical safety directives such as EMC and LVD.
- A thorough understanding of product testing standards required within the scope of the Medical Device Regulations.
- Exceptional communication skills, both verbal & written.
- Computer literate intermediate or advanced in Microsoft Office 365 packages (Excel advanced)
- The ability to work both autonomously and collaboratively with other departments to ensure timely and compliant product launches.
- Strong attention to detail, analytical skills and project coordination abilities.
- Commercial awareness and an ability to see the bigger picture whilst maintaining compliance.
About CareCo
At CareCo we celebrate our people — their milestones, their growth, and the everyday moments that matter. Our benefits are built to support your life, not just your work. As a Facilities Coordinator, we’ll offer you:
- 32 days annual leave (including bank holidays), with extra days when you stick with us
- Option to buy and sell annual leave
- Access to CareMiles, our exclusive staff benefits platform with discounts and cashback on various brands
- 25% employee discount*
- Life-event vouchers to celebrate milestones such as welcoming a new baby or getting married
- Employee loyalty rewards, including holiday vouchers
- 45p per business mile, tax free
- Free on-site parking
- Driving lesson contribution to help you learn to drive*
- Employee Assistance Programme for 24/7 confidential support
- Life insurance
- Cycle-to-Work scheme*
- Free annual flu jab
- Annual eye test contribution
- Employee referral scheme – earn £500 for referring a friend
- Reimbursement of professional membership related to your role
Whoever you are and whatever your story is, we’d love to hear from you. Apply to become part of a team that makes every day a better day.
We are proud to be a Disability Confident Employer which helps to employ, support and develop disabled people in the workplace.
*Eligibility for benefits based on length of service
Pay: £40,000.00 per year
Benefits:
- Company pension
- Cycle to work scheme
- Employee discount
- Free flu jabs
- Free parking
- Health & wellbeing programme
- On-site gym
- On-site parking
- Referral programme
Work Location: In person
