Please refer to JobSuchmaschine in your application
QA regulatory software
Amaris is an independent and international Consulting Group specialized in Management and Technologies.
Amaris operates in over 45 countries delivering services in Business & Management Consulting, IT/Information Systems, Telecommunications & Networking, Engineering, Pharmaceutical & Biotechnology.
Since 2007, the company has grown exponentially and is committed to building lasting relationships with its clients, delivering innovative solutions from project inception to execution.
- Ensuring that the company's products comply with international quality and regulatory requirements and Corporate rules to allow an efficient time to market.
- Supporting R&D platforms activities before and along product development or product changes, by defining the better regulatory pathway then ensuring the compliance to applicable requirements.
- Participation to product risk management activities.
- Review of design documentation along the development (design inputs, V&V, design ouputs, marketing claims, risk management, labelling requirements, …).
- Bachelor’s Degree from an accredited college or university
- 5 years of experience in quality assurance of biological or pharmaceutical or medical device
- Knowledge in international medical device regulations
- Knowledge of quality management standards IEC 62304
Languages : english (French or German is a plus)