Technical Assistant (m/f/d) with Amity Ltd. Amity Ltd. (https://www.amityinternational.com), an innovative supplier of specialty chemicals for the healthcare, aerospace, food, and industrial sectors, continues its strong growth trajectory under Belimed AG — a global leader in medical sterilization, disinfection, and cleaning solutions. Amity plays a crucial role in developing high-quality solutions that support hospital CSSDs worldwide. We are looking for a Technical Assistant (m/w/d) to join our headquarters inBarnsley, UK. How you will contribute In this role you will support the Technical Manager with the creation of all technical documentation as well as with other quality management activities, such as complaint management, CAPA management, vigilance reporting and SOP creation and monitoring. Your main responsibilities will include: + Assist in handling complaints, CAPA, and vigilance issues, ensuring timely closure to meet quality KPIs. + Support the development of medical chemical product specifications and formulation assessments with contract manufacturers. + Assist in creating legally compliant documents, including User Requirement Specifications, Labels, Post Market Surveillance, Risk, and Design History. + Manage and update product specifications, including reviewing incoming goods specifications (CoA/Labels). + Handle partner requests and ensure timely submission of international product registrations. + Develop SDS according to REACh requirements and align technical documentation with marketing materials and claims. + Assist in internal and external audits, ensuring compliance with QMS standards. + Participate in supplier qualification processes to maintain regulatory and quality compliance. + Support training program development and identify opportunities for process improvements in quality systems. + Assist in managing design changes and product lifecycle updates to meet regulatory expectations. What you will need + Degree (chemistry or other science) with experience in the field of medical devices. + Additional qualifications regarding MDR, Risk assessment, SDS creation or H&S is an advantage. + Experience with ISO 13485:2016, ISO 9001:2015, Risk Management (ISO 14971:2019), and Complaint/CAPA management. + Expertise in EU MDR & UK MDR Technical Documentation (Clinical Evaluation knowledge is an advantage) and SDS creation under REACh. + IT competent with knowledge of SDS software (preferably Excess). + Integrity and a proactive mindset with a strong sense of ownership and responsibility. + Strong ability to assess challenges and implement effective solutions. Why join our team + Work in an international, fast-growing industry that makes a real impact on healthcare. + Be part of an innovative and open-minded team. + Join a company with a strong reputation and long-standing expertise in cleaning and disinfection solutions. + Additional benefits of joining the company include a strong team ethic, Birthdays off, opportunities for growth and working for a small but impactful business. Ready to make an impact? Apply now and join Amity’s mission to improve healthcare worldwide! >>>APPLY ONLINE NOW In case of dossiers from employment agencies, the terms and conditions for the placement are negotiated individually in each case. General conditions are not accepted. Belimed AG processes personal data in accordance with the Belimed privacy statement available under:https://www.belimed.com/en/privacy-statement.