Senior Regulatory Affairs Associate, Jobs, Scotland, Glasgow, 5330

Engineering, Manufacturing & Supply Chain Recruitment

Senior Regulatory Affairs Associate - Glasgow

Engineering & Manufacturing - Engineering & Manufacturing
Ref: 5330 Date Posted: Thursday 15 Feb 2018

Nine Twenty Engineering are assisting in the recruitment of a Senior Regulatory Affairs Associate for our West Central Scotland based Client. 

The Role:

Vascutek’s Regulatory Affairs team ensure that our products and procedures are compliant with industry and governmental standards worldwide. 

The Regulatory Affairs team require an enthusiastic and conscientious individual to assist with the Regulatory workload associated with Vascutek’s medical device portfolio. 

Key responsibilities and duties will include; 

• Review and assist in the production and review of design dossiers, technical files, device master files and product approval certificates 
• Preparation of regulatory submissions for international product approvals 
• Preparation of paperwork for Custom-made devices and Special products 
• Participate in Design Control, Risk Management and Post Market Surveillance 
• Facilitate compliance with Vigilance System 
• Update and review all IFU, Packaging and Labelling 
• Oversee day to day responsibilities of RA Associates in relation 
to regulatory affairs functions 

Essential Skills and Experience: 

• BSc Hons degree or equivalent 
• Excellent attention to detail 
• Knowledge of MS Office Packages 
• Team player with the ability to work well under pressure 

The ideal candidate should also have good communication skills, both written and verbal. 

If you have the skills and Experience required for this role please submit your CV  to Nicole Lavelle for consideration.