_____________________
_____________________
____________________
______________________
_____________________________
_______________________
_______________________
________________________
_______________________
_____________________
R&D Engineer Medical Devices South Kent c.£45k bens Are you a Scientific Engineer with experience developing Medical Devices? Do you have a passion for R&D? Do you want to work for a market leading company with room for growth?! This is a fantastic opportunity for a Research & Development Engineer to join a large global Medical Device manufacturer to support them with the production of new products. Working in the exciting and fast paced NPI side of the business, your job will be to ensure that new products are the best they can be! Working to better the lives of patients you will be rewarded with a competitive salary and generous benefits package, as well as the opportunity to work with experts in this sector. As an R&D Engineer for this business, your duties will include: Working on a range of projects focused on production or improvement of medium- large sized components or systems for medical devices focused on the airways. Conduct testing and troubleshooting for assigned research projects. Resolve technical issues related to production, ensuring technical work meets requirements. Ensure compliance is always operating to all regulations and practices. Independently plan, schedule and coordinate projects assigned to production. Performing coaching/training for entry level engineers and supporting them through their development. Document all engineering activities during production. Communicate across departments to ensure smooth process. The successful Engineer will have/be: Educated to degree level in a relevant Scientific field this is an essential requirement Significant experience working within R&D for a Medical Device manufacturer this is essential due to the nature of the role Passionate about innovative engineering A great problem solver! The ability to handle priorities effectively to meet deadlines under pressure through effective time management. A creative thinker who can convey ideas clearly. Injection moulding experience would be a distinct advantage. This company are real investors in people and believe in offering funding for further study and progression opportunities to their workforce. This is an exciting role which will have a direct impact on people's health and wellbeing what could be more rewarding?! If you believe you meet the above criteria, please apply for immediate consideration! Please note, I cannot consider candidates who require sponsorship for this role, so please do not apply if you do not already have the right to work in the UK with no restrictions. This role is being handled by Emily Powell, Manufacturing, Engineering & Technical Specialist at Pearson Whiffin Recruitment Not quite the right role but still looking? Whether you are entry or Executive level, our team of experienced Recruitment specialists can help you with your career. We are Kent's leading independent consultancy and pride ourselves on delivering an exceptional service to both candidates and clients. Find us on Facebook @PearsonWhiffinRecruitment and Instagram @PearsonWhiffinRecruitment.
Job Title: Medical Device Project Engineer Location: Suffolk, UK Are you an experienced and driven Medical Device Project Engineer seeking a new and exciting opportunity? We are working with a dynamic and innovative company based in Suffolk, looking to expand their team with a talented individual who possesses a strong background in manufacturing medical devices, expertise in ISO13485, and a relevant education within the industry. Responsibilities: Lead and manage medical device projects from conception to completion, ensuring adherence to timelines, budgets, and quality standards. Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to drive successful project outcomes. Develop and maintain project documentation, including design specifications, risk assessments, and project plans. Ensure compliance with industry standards, particularly ISO13485, and contribute to the continuous improvement of quality processes. Identify and mitigate risks, troubleshoot technical issues, and provide innovative solutions to challenges in the medical device manufacturing process. Requirements: Bachelor's or Master's degree in a relevant engineering discipline (e.g., Mechanical Engineering, Biomedical Engineering). Proven experience in project engineering within the medical device industry, with a focus on manufacturing processes. In-depth knowledge of ISO13485 and other relevant quality standards. Strong problem-solving skills and the ability to work in a fast-paced, collaborative environment. Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams. Benefits: Competitive salary commensurate with experience. Comprehensive health and dental benefits package. Opportunities for professional development and career advancement. A collaborative and innovative work environment. How to Apply: If you meet the above criteria and are excited about the opportunity to contribute to cutting-edge medical device projects, please submit your CV or contact Lewis Woollard direct on .
Job Title: Senior Regulatory Affairs and Clinical Lead Job Type: Full time, permanent position Location: West Oxfordshire, (On-site) Remuneration: £100,000 This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home and hospital settings. With a diverse, global network serving customers in more than 160 countries, the organisation creates new solutions across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, the business is advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The business is currently looking for a Senior Regulatory Strategy Lead to join the team and take the lead on developing, creating, and implementing regulatory strategies for developing and establishing medical devices. Key Responsibilities Drive robust regulatory strategies for both developing and established devices ensuring all regulations are adhered to at both local and global levels. Lead all interactions with notified bodies, drive pre-submission meetings and support all cross-functional team. Support in both aspects of regulatory and clinical including CTAs, clinical and non-clinical. Lead a team of mixed-ability professionals in both regulatory and clinical offering training, development, and mentoring. Provide strategic input and technical guidance on regulatory authority queries. Oversee processes involved with maintaining annual licenses, registrations, listings, and patent information. Develop global regulatory strategies and update them based upon regulatory changes. Conduct regulatory due diligence for potential and new acquisitions and advise management. Utilize technical regulatory skills to propose strategies on complex issues. Lead crisis management program development and implementation. Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges. Lead processes and team involved with obtaining and maintaining product registration, release authorization, and release of products to specified geographies. Drive regulatory strategies including working cross-functionally with other departments to ensure the right strategy is defined. Provide training and mentoring to junior colleagues with the scope to get into line management depending on the individual's preference. Interact with notified bodies and keep well-versed in global regulations. Requirements University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering, or equivalent experience. Previous line management experience managing a broad range of individuals at all levels. Non clinical and clinical experience and being able to input into both RA and Clinical. Experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC). Previous lead strategies for a large product portfolio including supporting new registrations, authoring technical files, and post-market surveillance. Minimum of 8 years post-qualification experience in regulatory affairs in the medical device and/or pharmaceutical industry in product registration, medical device file, and/or technical compliance activities. Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organsiation offers a highly attractive benefits package that includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements. If you are interested in this role or would like more details please email your CV