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Job Description – QA/RA Manager (UK & EU) Location: Remote (UK or EU based) Reports to: Head of Operations / CEO Function: Quality Assurance & Regulatory Affairs About the Company We are an innovative women’s health company focused on developing and commercialising medical devices that empower people to manage menstrual and reproductive health. Our first product is a wearable pain relief device that delivers safe, non-invasive therapy, and we are scaling operations across the UK and EU markets. Role Overview The QA/RA Manager will lead quality assurance and regulatory affairs across the UK and EU, ensuring compliance with MDR (EU 2017/745), UKCA, ISO 13485, and other applicable standards. This individual will be responsible for maintaining the Quality Management System (QMS), driving regulatory submissions, managing audits, and supporting product lifecycle compliance from design through post-market surveillance. This is a hands-on role suited to someone with experience in small, fast-growing medical device companies, who can combine strategic oversight with operational execution. Key Responsibilities Regulatory Affairs • Develop and execute regulatory strategies for CE marking (MDR) and UKCA certification., • Prepare and maintain Technical Documentation, Clinical Evaluation Reports, and regulatory submissions., • Act as primary contact with UK Notified/Approved Bodies and regulatory authorities., • Monitor evolving regulatory requirements across UK/EU and update internal processes accordingly., • Maintain and improve the ISO 13485-compliant Quality Management System (QMS)., • Manage internal audits, external audits, and supplier quality oversight., • Develop risk management documentation in line with ISO 14971., • Oversee complaint handling, vigilance reporting, and post-market surveillance activities., • Partner with product development, clinical, and commercial teams to ensure compliance from R&D through to market., • Provide QA/RA input during product development, labelling, advertising, and promotional material reviews. Essential: • 5+ years of experience in QA/RA within the medical device sector., • Strong knowledge of EU MDR (2017/745), UKCA requirements, ISO 13485, and ISO 14971., • Proven track record of CE marking submissions and regulatory approvals., • Experience in managing audits with Notified/Approved Bodies., • Excellent documentation and technical writing skills., • Experience with active therapeutic devices, wearables, or women’s health technologies., • Knowledge of FDA 510(k) submissions (Class II devices)., • Experience in building or scaling QMS in a start-up environment., • Familiarity with risk-benefit analysis in pain relief or reproductive health devices.

HR Advisor – Change Working hours - Monday to Friday, 8:30am – 5pm Location - Remote role with a requirement to travel to various site locations when necessary (The wider HR Change team are based across the UK) We are looking for an organised HR Advisor to join our HR Change team. You will be supporting the wider change & operational team supporting TUPE activity, redundancy, restructure and organisational change processes. Key Accountabilities • Support the Change lead in providing managers with a pro-active and informed service that includes support, advice, guidance and interpretation of Employment Legislation, HR policy and practice, specifically in relation to all change activity which includes TUPE in and out of the business, all redundancy, restructure and organisational change processes, • Ensure activity is managed in line with our People First approach and decisions are commercially risk assessed in line with litigation risk, • Working collaboratively to produce redundancy calculations and other exit costs inc. settlement agreements, • Manage a change activity case load, while working within SLA’s, • Ensuring engagement is maintained and managers act in a way that involves employees and fosters a positive work environment not losing sight of our mission to make Bidvest Noonan a great place to work, • Ensuring managers are upskilled to deal with people change related challenges in a fair and effective manner, • Contribute to the completion of regular and customised management information and reports for senior management on a timely basis, interpreting trends and findings and providing insight into the data, • Analyse and generate data sets to identify trends, errors, and data corruption, undertake investigations and make recommendations to effect corrections and improvements as needed Skills & Experience required • Experience in similar HR roles, • Knowledge and/or experience of employment legislation in particular TUPE regulations and redundancy and restructure, • Evidence of working successfully with central functions in a shared services environment, • Comfortable working in a fast paced environment and/or industry, • Exceptional and demonstrable record of delivering against targets, • Excellent networking skills and stakeholder engagement skills, • Strong data management skills using excel, • Driving license and access to a car

Application Support Analyst - 1st Line Support. We are seeking a proactive and customer-focused Application Support Analyst to join our 1st Line Support team. You'll be the first point of contact for our clients, resolving incidents, answering queries, and ensuring a high-quality support experience.

You'll provide first line response to all building support requests and work orders raised.As our go-to person, the one with the know of how to keep the development running like clockwork, you'll oversee and and carry out fabric and minor repairs.You will work Monday - Friday between the hours of 8:

Interested? Take a look below to understand what youll be doing as Application Support Analyst:. Providing first-line support and incident resolution, escalating only where necessary. Supporting system access, service restarts, and essential monthly mai.

We are seeking a First Line Manager to join a well established goods handling business based in Sherburn in Elmet. Conduct regular performance reviews and support team development through training. If you are interested in the First Line Manager position based in Leeds, Sherburn in Elmet please appl

The purpose of this role is to provide oversight into the world of cyber security at ii and provide first line cyber security support in our SecOps Team. You will gain exposure and experience to a number of leading cyber security tools as well as cyber security process and procedure around policy, s

You will provide first line HR advisory and administrative support to designatedbusiness units,working in partnership with managers and Senior People Business Partners to provide an effective and commercial people service. You will manage the full life cycle of a range of employee relations cases, e

Strong knowledge of risk management best practice and emerging risk management developments within financial services; international risk management experience desirable. Engage and train senior leaders / risk owners and first-line stakeholders to embed a risk-aware culture and support their role as

The Service Desk Engineer is responsible for handling first, second, and third level support of service requests. Service awareness of all organization’s key IT services for which support is being provided. Line Service Desk Engineer with Accreditations and Training Provided.

Job Title: Facilities Assistant / Security Salary: £24,308 per annumClosing Date: About the Role We are seeking a F acilities Assistant / Security to provide a safe and welcoming service for our students, staff and visitors on campus. You will ensure our students (as well as staff) are wearing their ID cards in line with our Safeguarding Policy. Based at our Printworks Campus, this role is part of a growing team responsible for ensuring that teaching and learning activities are able to run effectively by supporting the campus building requirements. This role is 37 hours per week, working over 5 days on a rota basis to cover shifts. The campus mainly operates Monday to Friday in term time. What You Will Do • Work alongside the Facilities Assistant team as well as the Facilities Supervisor to ensure the smooth running of day-to-day Campus operations., • Provide effective guarding and patrolling of internal and external areas to ensure a safe and secure environment., • Unlocking and Locking up of the premises including setting of the Intruder Alarm., • Assist the site team and provide support with the Emergency Evacuation Procedures such as fire alarm activations and any other emergency., • Support the Facilities Supervisor with on-site contractors and visitors, ensuring an understanding of the College guidelines and procedures., • Assist the team with any other duties such as occasional events and exam set-ups. About You, • Commitment to self-development and to deliver outstanding customer service to all our students, staff & visitors., • Stay focused on the tasks in hand and be able to deal with challenging situations in a calm and measured manner?, • English and Maths GCSE or equivalent is essential, along with a willingness to take part in a First Aid at Work course with the college and undertake all mandatory online training., • Having an SIA door supervision licence would be desirable but not essential as training will be provided., • We do not recognise submissions of unsolicited or speculative CV applications from recruitment agencies., • We shall not be liable for any fee / commission in the event we employ a candidate that may have been submitted as an unsolicited/speculative application from an uninstructed recruitment agency.