Regulatory Affairs Consultant

Engineering jobs >> Manufacturing

Negotiable

Contract

Description

REGULATORY AFFAIRS CONSULTANT – BIOTECH / LIFE SCIENCES / MEDICAL DEVICES
  
BASED LIVINGSTON – 15 MONTH CONTRACT – DAILY RATE NEGOTIABLE
  
Based in Livingston, ESS’ client is a well-known and highly successful medical device business. With over 25 years’ experience of medical device development and manufacture, the business offers a wide range of ophthalmic viscoelastic devices (OVD) for use in cataract surgery and orthopaedic products, for sale throughout the world. Due to a maternity leave of absence, the business requires a Regulatory Affairs Consultant for a period of 15 months.
  
Reporting into the Head of Regulatory Affairs, the Regulatory Affairs Consultant will assist with ongoing projects to meet the requirements of the European Medical Device Regulation (MDR). The role will include assessing and updating existing technical documentation and product labelling to prepare for conformity assessment under the new regulation. The successful candidate will proactively identify and interpret new implementing acts, guidance and standards. 
  
The role will also involve assisting in the assessment of the regulatory impact of product and process changes and/or preparing global regulatory submissions in accordance with the business strategy and objectives for the company. 
  
Other key responsibilities will include:
*Assessment and update of technical documentation and product labelling to prepare for conformity assessment under MDR.
* Preparation of global regulatory submissions in accordance with the business strategy.
* Assist with the assessment of the regulatory impact of product and process changes.
  
The candidate will be degree educated in a technical or scientific discipline, with relevant post academic experience within the in vitro diagnostic or medical device sector.  Possessing a strong understanding of EU regulatory requirements, with knowledge of other international regulatory requirements, is desirable but not essential. 
  
In addition, the candidate will have excellent written and verbal communication skills; be structured and well organised with superior administrative skills and strong attention to detail.  With the ability to grasp complex scientific or technical information, the successful candidate will be accustomed to reading and interpreting regulatory documentation.
  
This position presents an excellent opportunity for someone seeking to broaden their experience of class III and class IIb implantable devices. Competitive salary, flexible start and finish times and a quarterly bonus scheme are also offered.
  
To apply to this role please contact our retained recruitment partner Sara Zorriasatein at ESS Holdings
  • 1
  • Negotiable
  • None
  • None
  • CV-117526
  • Contract
  • 0

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