Full time / Bradford - Cleckheaton

About Winncare

At Winncare, we are dedicated to enhancing the quality of life for individuals in need of mobility and care solutions. With over four decades of expertise, we specialise in developing and providing innovative products and services that support the healthcare industry, including lifting and transfer equipment, medical beds, and a wide range of care solutions.

Our commitment to excellence is driven by a passion for improving the everyday lives of patients and caregivers alike, ensuring safety, comfort, and dignity for those we serve. As a trusted partner in healthcare, Winncare continues to lead with innovation, compassion, and a relentless pursuit of quality.

This is an exciting time for Winncare as we experience organisational growth and new opportunities to join our highly skilled, professional, and committed team in a great working environment.

Due to our growth and to support the continued delivery of excellent service to our customers and the sector, we are now seeking to appoint a qualified, experienced and highly capable Senior Regulatory Affairs Associate.

Reporting to the UK QA/RA Manager, the successful candidate will play a critical role in ensuring regulatory compliance for the company's medical devices, overseeing submissions, documentation and approvals to support product lifecycle management and market expansion.

This role involves collaborating with cross-functional teams to ensure that our devices meet EU MDR, and other global regulatory requirements, supporting product development from concept through post-market activities.

Key tasks and accountabilities associated with the role are as follows:

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• Regulatory Submissions: Prepare, compile, and submit regulatory documentation for new product approvals, modifications, and renewals, including 510(k), PMA, CE Marking, and international submissions as required.
• Regulatory Strategy Development: Develop regulatory strategies to ensure timely and effective approval of new products and modifications, considering both U.S. and international requirements (e.g., FDA, EU MDR, Health Canada, TGA).
• Regulatory Compliance: Ensure ongoing compliance with applicable medical device regulations, standards, and guidance documents across the lifecycle of each product. Maintain knowledge of current and emerging regulations and communicate updates to relevant stakeholders.
• Quality System Support: Work in conjunction with Quality Assurance to ensure compliance with 21 CFR Part 820, ISO 13485, and other applicable standards. Support internal audits, regulatory inspections, and assist with Corrective and Preventive Actions (CAPA).
• Labelling and UDI Compliance.
• Technical Documentation: Prepare, maintain, and update technical files, Design Dossiers, and Device Master Files (DMF).
• Risk Management: Support risk management activities and ensure that risk assessments are documented, reviewed, and incorporated in regulatory submissions.
• Post-Market Surveillance and Vigilance.

Applicants should possess the following skills, qualifications and experience:

Education: Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field.

Experience: approx. 3 years of experience in Regulatory Affairs within the medical device industry, with a focus on EU MDR submissions and compliance.

Knowledge: Strong understanding of EU MDR, as well as international regulations (ISO 13485, Health Canada, TGA, FDA etc.).

Skills:

• Proven experience in preparing and submitting regulatory filings (EU MDR technical files)
• Strong project management skills with the ability to handle multiple projects simultaneously.
• Excellent written and verbal communication skills, with attention to detail in documentation.
• Ability to interpret complex regulatory standards and communicate requirements effectively to cross-functional teams.
• Proficiency with regulatory documentation tools and software.

Due to the geographical locations of the Company and client base, it is essential applicants hold a full UK driving licence. As this is an office based role, applicants should live within easy commutable distance of the office in Bradford.

This is a great opportunity for a suitably qualified and experienced individual to join a committed and dedicated team at a time of growth in a rewarding and engaging environment and a great workplace community.

If you possess the skills, knowledge, and experience suitable for this vacant post, please apply.