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Regulatory Affairs Specialist - South London - Southern

Competitive salary and benefits package (FLEXIBLE HOURS) - Medical/Pharmaceutical - Regulatory
Ref: 180 Date Posted: Wednesday 20 Jun 2018
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A world leader in the design and manufacture of neonatal ventilators and related products are on the hunt for an experienced Regulatory Affairs Specialist. You will assist with the management of regulatory affairs and deputise for the Regulatory Affairs Manager, as necessary. If you strive for perfection and have a keen eye for the most intricate details, then this could be ideally suited for you.

 

The Opportunity

 

Working closely with the quality assurance and design teams you will have expert knowledge of worldwide regulatory standards and demonstrable experience of ISO 13485, CE marking, technical file submissions and driving regulatory processes and activities. There will be an initial focus on providing a gap analysis of our current product portfolio and developing remediation plans to meet current medical device requirements.

 

Essential Requirements

 

  • Demonstrated Regulatory experience in active Class IIb and III medical devices  
  • Experience dealing directly with Notified Bodies, Competent Authorities and MHRA  
  • Hands on experience of creating compliance documentation
  • Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971
  • Excellent communication skills
  • Strong organisational skills, including the ability to prioritise workload
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, manufacturing and commercial  

 

The Company

 

Based in South London, our client is one of the leading global providers of neonatal ventilation products. In this highly specialized field, they remain the only company to exclusively concentrate on this area of expertise ensuring the highest quality products are delivered every time.

 

The Next Step

 

Medical Engineers would invite enquiries from research and development leaders from the medical technology and other highly regulated industries, regardless of your current team size and structure we will treat all communication in strict confidence.

 

Calls can be arranged outside office hours, please let us know in your communication and we will get this arrange in a time to suit you.

 

 

Direct 0161 260 0190

Email: Recruitment@medicalengineers.co.uk

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At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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