Job Description
Position: Senior Drug–Device Combination Documentation Expert
Location: On-site - Bulle, Switzerland
Client: Biotech
Type: 12 months contract initially - full-time (40hours per week)
About the Role
Senior expert in drug–device combination product development, with a strong focus on autoinjector platforms.
Strategic and hands-on role covering development, industrialization, and documentation.
Drives technical robustness, regulatory compliance, and risk-based decision-making across programs.
Main Responsibilities
Lead risk management activities for autoinjector combination products from concept to commercialization.
Ensure compliance with global medical device and combination product regulations and standards (e.g., ISO 13485, ISO 14971, ICH Q8/Q9/Q10/Q12, 21 CFR Part 4, EU MDR Article 117).
Collaborate with cross-functional teams to align on timelines, design controls, and quality system requirements.
Support selection and implementation of tools to e...
Location: On-site - Bulle, Switzerland
Client: Biotech
Type: 12 months contract initially - full-time (40hours per week)
About the Role
Senior expert in drug–device combination product development, with a strong focus on autoinjector platforms.
Strategic and hands-on role covering development, industrialization, and documentation.
Drives technical robustness, regulatory compliance, and risk-based decision-making across programs.
Main Responsibilities
Lead risk management activities for autoinjector combination products from concept to commercialization.
Ensure compliance with global medical device and combination product regulations and standards (e.g., ISO 13485, ISO 14971, ICH Q8/Q9/Q10/Q12, 21 CFR Part 4, EU MDR Article 117).
Collaborate with cross-functional teams to align on timelines, design controls, and quality system requirements.
Support selection and implementation of tools to e...
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