Device Development Lead
An exciting opportunity has arisen for a Device Development Lead in Switzerland. In this role you will be expected to lead cross-functional exercises to define targeted device profiles.
- Lead cross-functional exercises to define targeted device profiles.
- Develop device development project plans and budget with internal and external cross functional teams.
- Deliver quality products and processes with appropriate validation and regulatory documentation.
- Report and tightly control device development timelines, budget and risks to bio-similars project development team.
- Act as the main interface between the bio-similars project development teams and the sub teams (e.g. medical devices, manufacturing & supply, etc.) as well as device vendors.
- Provide technical and business inputs to projects. Analyse risks and suggest mitigation plans.
- Oversee device development, manufacturing, validation and regulatory activities.
- Proactively anticipate and identify risk areas and alert stakeholders appropriately.
- Report and escalate to management potential issues as needed.
- Identify new device opportunities
Skills and Requirements
- Life sciences or chemistry graduate to honours level or equivalent
- Must have UK market regulatory experience within pharmaceutical regulatory affairs and working with MHRA directly, ideally with some OTC experience
- Brexit related regulatory knowledge and experience
- Must have hands on experience in management of day to day UK and EU regulatory procedures
- Ideally knowledge and experience of allied regulatory affairs areas such as Cosmetic, Medical Devices but not essential
- Works with minimal supervision to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives
- Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity including processes.
- Project management, understanding of regulatory environment, interaction with the Regulatory Authorities (as appropriate), commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations etc
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.