Device Development Lead

Highly Competitive
  1. Permanent
  2. Medical Advisor
  3. Switzerland
Nyon, Switzerland
Posting date: 18 Mar 2021
36400

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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