98 days ago on amaris.com

QA regulatory software

Amaris Sàrl

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 Please refer to JobSuchmaschine in your application

QA regulatory software

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.

Your role:

- 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, …).


Your profile:

- 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)

Country:SWITZERLAND /  Location:Geneva