Quality, R&D, Medical Devices and Combination Products Manager

I am currently working with a top 10 pharma who’s expanding pipeline help them take on the world’s toughest health challenges in oncology, immunology, liver disease, women’s health and beyond. They are striving to make a real difference to patients around the world. Together we are looking for a Quality Manager to join their R&D team specializing in Medical devices and combination products.

Responsibilities:

• Focus on development of medical devices and combination products from a QA perspective
• Review and approve device related development documentation
• Partner with third party development firms
• Demonstrate leadership by leveraging your expertise in design control, risk management and human factors
• Lead global cross-functional improvement projects
• Support regulatory submissions and represent the company in regulatory authority inspections

Requirements

• Bachelors or technical degree in engineering or related scientific discipline and 6+ years’ experience in area related role
• In depth knowledge of medical device development, combination products and cGMP regulations
• Strong analytical approach
• Experienced in leading projects in a cross-functional environment
• You are an excellent communicator and work effectively in multi-disciplinary and cross-functional teams
• Fluent in English & German

If you think that you have the skill set required to make my shortlist please get in touch sooner rather than later!!!