Medical Device Development Specialist
PharmaMedTechRegulatory AffairsQuality Assurancegmpregulatory submissioncroinform
Job description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client’ site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries! We’re proud to be an armed forces-friendly place to work and welcome applications from reservists, armed forces veterans (including the wounded, injured and sick), as well as cadet instructors, and military spouses and partners. If you want to continue to help make our world a safer and healthier place, then apply for the role below and become a part of the extraordinary Eurofins network Unfortunately, we are unable to offer visa sponsorship for this role. This is a full time, permanent position, working a flexible 37 hour week, Monday – Friday. As a Device Development Lead, you will be responsible for supporting cross-functional project teams in the development, industrialisation, verification and validation of drug delivery devices. You will work closely with internal scientific, manufacturing, quality, regulatory and commercial stakeholders, as well as external design and manufacturing partners, to ensure projects are delivered on time, within budget and to the highest quality standards. . Job Responsibilities that you be covering: You will lead multidisciplinary medical device development projects, providing technical leadership and mentorship while acting as a key device development representative across internal and external stakeholder groups. You will manage the full device development lifecycle, from concept evaluation and specification development through design, design control, risk management, verification, validation and industrialisation activities.You will coordinate activities with external design, development and manufacturing partners, ensuring successful project delivery against quality, cost and timeline objectives. You will support human factors and usability studies, contribute to combination product development programmes and help develop innovative healthcare solutions that improve patient outcomes. You will contribute to complaint investigations, technical issue resolution and design change control activities, ensuring compliance with quality, regulatory and continuous improvement requirements. You will support supplier assessments, capability evaluations, regulatory submissions and the preparation of technical documentation to maintain the highest standards of quality and compliance. What skills, qualifications and experiences you will hold as an Medical Device Development Specialist: You will hold a degree in Chemical Engineering or a related scientific or engineering discipline, with knowledge of pharmaceutical development environments and an understanding of medical device development processes being highly desirable. You will have a strong understanding of GxP requirements and experience working within regulated environments, with the ability to apply quality-focused principles to support compliant operations. You will have proven problem-solving and troubleshooting skills, with the ability to quickly learn new processes and develop effective solutions both independently and as part of a collaborative team. You will have excellent communication and relationship-building skills, enabling you to work effectively with internal colleagues, external partners and cross-functional stakeholders. You will have strong organisational, documentation and IT skills, including confidence working with fully electronic systems and Microsoft Office applications while maintaining accuracy and attention to detail. You will have a flexible and adaptable approach, a passion for quality and customer service, and the ability to thrive in a fast-paced, dynamic environment with changing priorities. At Eurofins we are growing, innovating and always learning. We celebrate the achievements of our employees through annual long service awards, recognise our colleagues special life events, and we are committed to charitable causes through global fundraising activities. As a Eurofins employee you will benefit from: Being part of a Reward and Recognition Scheme, recognising great work across our teams. Holiday entitlement increases with service. The option to opt into our Health Cash Plan, designed to help look after your everyday health and wellbeing. This allows you to claim back the cost of routine healthcare expenses such as dental check-ups, eye tests, glasses or contact lenses and other everyday medical treatments. Life Assurance from day one, providing cover of four times your annual salary. Automatic enrolment into our Company Pension Plan after three months (with the flexibility to opt out if you choose) Access to our Employee Assistance Programme, offering 24/7 confidential support for both personal and work-related matters. Being able to register your interest in volunteering days, which are designed to support employees who wish to do voluntary work during working hours as part of a wider strategy to contribute positively to the local community. Free on-site car parking. The opportunity to explore worldwide opportunities. Everyone who joins our team also gets access to Perkbox, allowing you to save money all year round. Whether its supermarket savings or days out, the daily coffee or a summer holiday – there’s something to suit everyone’s lifestyle. What Happens Next Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. Your data As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity an
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