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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.
- 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.
- 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. ?