124 days ago on amaris.com

Regulatory Affairs Manager

Amaris Sàrl

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Regulatory Affairs Manager

Regulatory Affairs Manager  |



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 the regulations of government agencies. 
- Keeping abreast of international legislation, guidelines and customer practices. 
- Collecting and collating a wide range of information. 
- Keeping up to date with a company's product range. 
- Developing and writing clear arguments and explanations for new product licenses and license renewals.  
- Update of technical documentation.  
- Understanding and evaluating complex information.  
- Working with specialist computer software and resources.  
- Writing clear, accessible product labels and patient information leaflets.
- Advising scientists and manufacturers on regulatory requirements. 

Your profile:

- Degree or equivalent in a Life Science 
-? Excellent communicator, both verbal and written. ?
- More than excellent command of English.
- Proven expertise of Medical Device Regulatory Affairs 
- At least 3 years experience in medical device
- Business development skill sets with exposure to or having worked in a regulatory consultancy model 
- Be able to demonstrate driving partnerships within the industry 
- Excellent attention to detail. ?

Country:SWITZERLAND /  Location:BASEL
Languages:German /English