Job Description
Working as a key member in our Quality Assurance and Regulatory team you will be tasked with ensuring we comply with ISO 13485 and MDR and CE mandates, you will be working with our QA/RA team, supply chain manager, product development department as well as our manufacturing partners and distributors. As part of a global team, you will be given opportunities to develop your knowledge of global regulations and training will be provided to ensure your professional development in this area. We are committed to developing our employee owners in a continuous learning culture - one where we challenge you with engaging work and where we look for every experience adding to your professional development.
Key Responsibilities:
You will be responsible for providing advice and support for regulatory operations / aspects of the TensCare medical device business. The function of the TensCare Quality Assurance and Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable product development, manufacture and distribution. You will be involved and responsible for maintaining our technical files, completing notified body product reviews, including clinical evaluation reports and making applications with Ministry of Health authorities to obtain licences/accreditation to sell TensCare products in different countries. You will be involved with writing and maintaining our QMS and learning our Greenlight Guru eQMS.
· You will serve as TensCare’s formally appointed Responsible Person (RP) for ISO 13485 accreditation and the Person Responsible for Regulatory Compliance (PRRC) under EU MDR, acting as the principal internal and external contact for all matters relating to quality and regulatory compliance. In this capacity, you will ensure that TensCare’s Quality Management System (QMS) is maintained, continually improved and fully compliant with certification and audit standards.
· Provide QA/ RA team resource for the day-to-day administrative management requirements to maintain and monitor the quality management system. Including but not limited to audits, CAPA, Non-conformities, control of documents and records, Complaints, PMS, continuous improvement, supplier records, trend analysis etc. .
· Contribute to and refine procedures, work instructions, templates and our quality manual to maintain our ISO 13485:2016 certificate.
· Work with our QARA team and Notified Body to maintain current certifications and achieve award of a CE mark, FDA or other markets’ approval on new products. This will include Contributing to and refine technical documentation necessary to maintain our current CE Markings and to complete a design dossier suitable for submission for new products.
· Prepare and maintain regulatory files such as Medical Device Technical Files;
· Review of process/product changes, labelling, claims, product complaints, A&Ps (Advertising & Promotional materials) etc., to determine the need for any regulatory activities and to ensure compliance to International regulatory requirements;
· In time with familiarity and training, perform internal audits to assess the company compliance with our QMS. Attend audits performed by internal team members and external authorities to represent TensCare’s QA/RA positions and processes;
· Build knowledge and maintain surveillance of the many relevant quality standards. Keep up-to-date with changes in regulatory legislation and guidelines.
· Provide technical support and resolve quality issues with suppliers, customers or auditors including introduction of new or re-designed components and processes.
· Support the TensCare Quality Management and Regulatory Affairs Associate, TensCare Leadership Management team, Product Design Manager and Supply Chain Manager. Writing and reviewing our Quality Management System, standard operating procedures and work instructions as well as maintaining records of documentary control and applying to various authorities for regulatory conformance around the world;
· Leadership and Line Management, we are looking to develop your role in the business. Working closely with the Supply Chain Manager, Product Development and Leadership Team to ensure compliance and quality standards are integrated across all operations. In this capacity the Part-Time QARA & Supply Chain Administrator, will be a direct report; with you providing guidance, support and performance feedback.
· Overseeing administrative processes that support both QARA and Supply Chain, including supplier compliance records, certification tracking, and documentation management.
· Working with the SCM and QARA & Supply Chain Administrator to ensure supplier documentation is current, complete and audit-ready.
· Help supervise forecasting and compliance data inputs to align with SAP and QMS systems. Mentor and develop team members to build cross-functional capability in compliance and supply chain documentation.
· In this developing role, you will contribute to cross-functional product development teams, supporting regulatory strategies and design risk management.
· Support business-wide initiatives and continuous improvement projects to enhance efficiency and compliance.
· Uphold company mission and values through accountability, innovation, integrity, quality, caring, cooperation and encouragement.
· Participate in cross-functional product development teams to understand and build development of regulatory strategies.
· Participate actively in other business-related projects (business opportunities, client specific issues, etc.) and planning.
· Regular assessments and discussions with the management team to ensure we remain audit ready and technically compliant. This list of duties is not exhaustive, and you may be asked to carry out other duties through discussion with your line manager. If there are gaps in knowledge to fulfil all the above tasks, we will provide training and development.
Essential Experience
· PRRC requirements:
o a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
OR
o at least four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
· Familiarity with regulatory frameworks such as MDR, FDA, Health Canada or MHRA requirements
· Previous experience in a quality management, quality assurance or senior compliance role.
· Experience supporting or leading external audits.
· Strong understanding of ISO 13485 Quality Management Systems, accreditation requirements, root cause analysis and CAPA management.
· Experience investigating customer complaints, quality incidents and non-conformances.
· Strong written communication, report writing, organisational and stakeholder management skills.
· Ability to influence, challenge constructively and maintain independence in quality decision making.
Desirable Experience
· Previous experience within a medical device business.
·
· Internal Auditor or Lead Auditor qualification.
· Experience managing quality and/or regulatory teams within a medical device manufacturer company.
· Knowledge of relevant medical device legislation and applicable standards.
Who we are:
TensCare is an employee-owned business where every member of the team has a say in how the company is run. We are Europe’s largest distributor of TENS machines with over 33 years of experience. We provide drug-free pain relief for the long-term treatment of chronic pain conditions and the relief of the acute pain of childbirth. Our electrotherapy devices provide muscle rehabilitation for post injury or trauma.
What is in it for you?
· 31 days holiday inclusive of Bank Holidays plus a day off on your birthday
· 3 Days work from office, 2 days work from home (Tuesday and Friday) (laptop provided by company)
Smart casual
· Company events
· Company pension
· On-site parking
· Private medical insurance
· Critical Illness Insurance
· Profit sharing
· Sick pay
· Performance related uncapped commission, paid monthly
Further information:
The TensCare offices are located in Epsom between Epsom train station and Ewell West station and there is an onsite parking.
Pay: £35,000.00-£42,500.00 per year
Benefits:
- Company events
- Company pension
- On-site parking
- Private medical insurance
Work Location: Hybrid remote in Epsom KT19 9BE
