Manager, Combination Products and Medical Devices (all genders) (fulltime, regular)

📋 Description

• Assure proper integration and support of device, drug and biologics regulations.
• Lead product team members through the design process providing guidance while working closely with
• Ensure design control documentation as well as design change control requirements are met by
• Perform 3rd party supplier management while reviewing and approving supplier design control
• Partner with third party vendors, manufacturers and laboratories to ensure that combination
• Foster close global collaboration with R&D, Operations and Commercial Operation functions to

🎯 Requirements

• Bachelor’s degree in biomedical engineering, mechanical engineering, or another relevant technical
• Minimum 6+ years of industry experience in Quality Assurance, development or healthcare related
• Understanding of regulations and standards affecting combination products and medical devices
• Sound technical understanding of product development (e.g. approaches for definition of
• Well-versed in risk management methodologies and their application.
• Able to take the initiative to identify and implement new approaches to resolve problems, able to

🎁 Benefits

• Diverse work environment where you can have a real impact
• Open corporate culture
• Attractive salary
• Intensive onboarding process with a mentor at your side
• Flexible work models for a healthy work-life balance
• Corporate health management that offers comprehensive health and exercise programs