Device Development Lead job in Nyon, Switzerland

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Medical Advisor

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

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.

Job Responsibilities

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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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