Device Project Leader

Our client is a pharmaceutical company that specialises in developing generic drugs and biosimilars to enable wider patient access globally. The company is seeking a Device Project Leader to join their base in Schaftenau, Austria. This is a permanent role.

Role Responsibilities:

• Lead, represent and manage complex and large cross-functional device development projects or platform project teams
• Accountable for project definition, establish project team, delivery and communication from development up until transfer
• Formulate and implement a scientifically sound and business driven project strategy incl. risk assessment and contingency planning
• Assess, consolidate and negotiate on an on-going basis all internal and external resource needs as well as timelines and budget
• Representative for all device project related activities during health authority inspections and interactions
• Monitor, support and challenge technical development as well as test and verification work
• Accountable for establishing a high quality Design History File (DHF).
• Lead and document design reviews / gap analysis and create reports
• Support and lead cross functional project teams in the development, review and submission of regulatory dossiers
• Support and coordinate the manufacturing of devices and combination products for clinical trials and supporting the production scale up
• Ensure compliance with Design Control and CMC requirements for FDA combination products regulations and applicable ISO requirements for U.S. and foreign marketed products

Role Requirements:

• University degree in a scientific or technical discipline
• Languages: English (fluent) / German (basics) beneficial
• Relevant practical experience of at least 10 years in the development and registration (up to commercialization) of drug delivery devices
• Broad and in depth technical knowledge of parenteral drug delivery devices
• Thorough and proven knowledge of GMP and international device regulations
• Proven project management skills, strong communicator and problem-solving skills
• Ability lead interdisciplinary, cross-cultural teams

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Max Kelly on +44 203 078 9569 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.