Global QA Project Manager – Medical Devices & Combination Products

Proclinical Staffing; Basel; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Proclinical Staffing is seeking a Project Manager with quality assurance expertise for medical devices and combination products. Lead global project teams, drive QA strategies, and ensure regulatory compliance across development programs.

You will oversee QA activities, interact with Health Authorities, and guide project strategies to meet submission timelines. English fluency is required, with additional languages a plus, and EU work rights or location-specific eligibility is necessary.

Qualifikationen

• Experience leading QA-focused projects for medical devices or combination products.
• Knowledge of regulatory pathways and submissions (FDA/EMA) for devices and drug-device combos.
• Proven ability to guide global project teams and align QA with development timelines.

Aufgaben

• Lead and support global project teams, representing QA in sub-teams and governance meetings.
• Provide QA oversight on development projects with strategic and technical guidance.
• Develop project strategies, risk assessments, and contingency plans to ensure timely delivery of quality outcomes.
• Ensure alignment with cGMP and internal QA procedures across programs.
• Coordinate interactions between QA and other functions and external partners.
• Communicate project status and critical updates to stakeholders and management.
• Contribute to contracts and QA agreements with third parties and approve amendments.
• Lead or participate in global, cross-functional initiatives.
• Prepare teams for inspections, including Mock-PAI and PAI activities.

Kenntnisse

Quality assurance

Regulatory compliance

Project management

Cross-functional teamwork

cGMP knowledge

FDA inspections

Notified Body inspections

IND/IMPD submissions

Tools

MS Office

Document management

Jobbeschreibung

Proclinical Staffing is seeking a Project Manager with quality assurance expertise for medical devices and combination products. Lead global project teams, drive QA strategies, and ensure regulatory compliance across development programs.

You will oversee QA activities, interact with Health Authorities, and guide project strategies to meet submission timelines. English fluency is required, with additional languages a plus, and EU work rights or location-specific eligibility is necessary.