J4193BerkshirePharmaceutical Medical Devices Engineering Permanent£55,000 to £65,000 per annumFull Time21/07/2017Engineering Engineering – Design
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We are currently looking for a Device Development Manager to join a Global Pharmaceutical business based in the Berkshire area. As the Device Development Manager you will be responsible for supporting the development of new assets, from concept through to commercialisation, with the focus on leading development activities of projects for the US market and supporting device development activities for other markets.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Device Development Manager will be varied however the key duties and responsibilities are as follows:
1. Interfacing with both internal and external resources to ensure development and delivery of Medical Devices and Drug Device combination products, ensuring compliance with appropriate regulatory guidelines and standards
2. Maintain a high level of design development and Good Manufacturing Practice (GMP) according to FDA and relevant US-based guidance relevant to medical devices and pharmaceuticals.
3. Manage external resources, manufacturers and suppliers to ensure optimal performance, delivery and compliance.
4. Review/input into appropriate regulatory and design development documentation.
To be successful in your application to this exciting opportunity as the Device Development Manager we are looking to identify the following on your profile and past history:
1. Relevant degree qualification in an Engineering or Design based discipline, whilst having extensive experience in Medical Devices/Pharmaceutical industry.
2. Proven industry experience with Medical Device development and knowledge of cGMP regulations for manufacturing activities. Knowledge of drug delivery devices would be beneficial.
3. You will have a broad knowledge of pharmaceutical manufacturing processes. Experience of regulatory guidance and requirements outside of FDA guidance, CE Marking as an example, is desirable.
Key Words: Pharmaceutical | Medical Device | Drug Delivery | cGMP | Design | Development | Engineer | Engineering
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.