Description
This company now operates in over 90 countries globally and is rapidly eating up market share; because of a huge success globally there is now a need for a Senior Regulatory Affairs Specialist for their Somerset based team.- Obtaining pre-market approvals, via direct liaison with global regulatory authorities.
- Keeping up to date with regulatory changes within the global Medical Device markets.
- Provision of regulatory assistance to the company sales and customer services teams in relation to tendering processes, and general support to new accounts.
- Regulatory and technical input in any New Product Introductions in areas such as:
- Design planning, Risk management, clinical evaluation, manufacturing control, packaging, labeling, sterilization and process validations,
- Upkeep and development of company Device Master Files.
Candidate Requirements
- Broad Expertise and Experience (minimum 5 years) in Medical Device Regulatory Affairs within the EU and international market place.
- Good understanding of manufacturing techniques and medical technology.
- Ability to self-manage and effectively interact with others in accomplishing objectives.
- Excellent verbal and written communication skills and interpersonal skills.
My client is looking to shortlist candidates over the next two weeks so if you believe you have the required experience then please send me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com