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Regulatory Affairs Specialist- £35,000-£50,000 DOEMarlborough, SN8 The Role Do you possess a strong understanding of medical device regulations, coupled with at least 3 years' experience in medical device regulatory affairs and MDR? If so, we have an exciting opportunity for you. We are a global wound care manufacturer, looking to appoint a knowledgeable and experienced Regulatory Affairs Specialist to our growing team. You will play a crucial role in our Quality Team. Your primary responsibilities will include managing MDR, CE/CA, product registration, and all regulatory aspects of post-market surveillance. You will ensure compliance with all applicable standards, regulations, and guidance to support both pre- and post-market requirements. If you meet the requirements and are ready to take on this challenging and rewarding role, we would love to hear from you. Key Responsibilities: As a member of the QA/RA team, liaise with First Water Ramsbury Ltd's R&D and Commercial Business Development to provide regulatory input into NPI projects. Timely preparation and submission of regulatory applications (eg: 510(k), CE Marking, Design Dossier, Product Registrations, IDE, Supplements, Annual Reports, PMA and PMA supplements) Interface with regulatory reviewers through written and oral communications as needed and assist in correspondence with review agencies, notified bodies, and trade associations on matters relating to product registrations and PMS. Liaise with other First Water Ramsbury Ltd departments serving as a Regulatory representative on cross-functional teams including, but not limited to, First Water Ramsbury Ltd Quality, R&D, Supply Chain and Operations and other Gentell Inc subsidiaries. Undertake deputised duties as required. The Company First Water Ramsbury Limited is part of a larger group of wound care providers supplying wound adhesive dressings and solutions, manufactured for the Healthcare and Industrial markets. We have a wide-reaching footprint, with manufacturing and operations facilities in Europe, North America and Canada. The Benefits Company pension scheme 5% contributions. Incapacity insurance for a 2 yr period. Death in Service of 3 x salary. Company sick pay scheme 4 weeks full pay followed by 4 weeks half pay plus statutory sick pay. Enhanced maternity benefits. The Person A degree or equivalent in a Life Science subject (Biochemistry, Biotechnology, Microbiology, Bioinformatics) and/or a significant area of expertise of Medical Devices developed through experience and a positive track record. Minimum of 3 years of experience in medical device regulatory affairs and MDR. Experience in clinical evaluation report writing for medical devices is essential. Detailed knowledge of the worldwide regulations and guidance for medical devices. Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements. Understanding of Quality Management Systems - FDA QSR, ISO 13485. Understanding of Supplier Management Detail-oriented and excellent written and verbal communication skills.
Production Shift Supervisor- £37,880 17% Shift PayMarlborough, SN8 The Role Are you skilled in managing teams and ensuring smooth production operations? Do you have the experience needed to maintain quality standards in a fast-paced manufacturing environment? If so, we have an exciting opportunity for you. We are a global wound care manufacturer, looking to appoint a highly organised and confident Production Shift Supervisor to our growing team. You will support the Production Manager in the safe and efficient running of a shift. You will supervise and coordinate the activities of workers engaged in manufacturing parts or products using both automated and manual processes. Shift pattern is 6am to 2pm and 2pm to 10pm alternate weeks Monday to Friday. 40 hrs per week. If you're ready to make a significant impact in our production team and help us maintain our high standards, we'd love to hear from you. Key Responsibilities: People & Safety Ensure that the working environment, working practices and general behaviour of all employees support the company policies, procedures and applicable laws. Supervise staff to ensure a harmonious and efficient production environment. Interpret business requirements to employees and assigns duties accordingly. Interface with others in the organization to ensure customer deadlines are met and ensure that the OTIF target of 100% is being achieved. Responsible for performance management, training and development of staff in conjunction with Production Manager and Production Trainers. Manage and control the physical work area to ensure a safe working environment at all times. Be technical lead for production running issues, resolve/escalate to Production Manager and Engineering team. Quality Inspect and measure parts and products to verify conformance to specifications and to support the introduction of quality initiatives. Supervise equipment adjustment to prevent manufacture of products which fail to meet standards. Maintain all relevant production and quality documentation as required In conjunction with the Quality and the Production Team, investigate and close Non-conformance Reports (NCR's) in a timely manner. Develop, recommend, and implement Standard Operating Procedures (SOPs) within the Clean room and Component Storage Area. Speed Coordinate and communicate daily production processes to ensure production schedules are met. Analyse work orders to estimate worker hours and complete relevant work order details as required. Feedback to Operators when gaps or deviations occur to standard requirement and work toward retrieval of lost time The Company First Water Ramsbury Limited is part of a larger group of wound care providers supplying wound adhesive dressings and solutions, manufactured for the Healthcare and Industrial markets. We have a wide-reaching footprint, with manufacturing and operations facilities in Europe, North America and Canada. The Benefits Company pension scheme 5% contributions. Incapacity insurance for a 2 yr period. Death in Service of 3 x salary. Company sick pay scheme 4 weeks full pay followed by 4 weeks half pay plus statutory sick pay. Enhanced maternity benefits. The Person Experience in a similar supervisory role within a manufacturing environment. Knowledge of quality control procedures and safety regulations. Ability to lift and/or move up to 25 kilograms. Specific vision abilities required: close vision, colour vision, depth perception, and the ability to adjust focus. Strong leadership and communication skills.