Regulatory Affairs Specialist, GET STAFFED ONLINE RECRUITMENT LIMITED

About the role

The Regulatory Affairs Specialist role provides technical support for the Regulatory Affairs Department, ensuring regulatory elements of international distribution of our client’s products, and implementation of changes to products in production are fulfilled. This role supports validation of product claims on a market specific basis and makes sure up to date documentation is available for all marketed products.

Responsibilities

• Supports validation of product claims on a market specific basis
• Makes sure up to date documentation is available for all marketed products
• Performs regulatory reviews of complaints for reportability, and reports as necessary

Requirements

• Holds a minimum of BSc Degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.)
• Comprehensive working knowledge of CE marking requirements for in vitro diagnostic medical devices or medical devices
• Knowledge of international regulations for medical devices
• Experience of working with Notified Bodies and Regulatory Agencies (desirable)
• R&D background would be beneficial

Qualifications

• Minimum of BSc Degree or equivalent experience in life sciences

Skills

• Good interpersonal skills
• Excellent written and oral communication skills

Benefits

• Hybrid working
• Annual discretionary bonus
• 25 days paid annual leave plus bank holidays
• Company pension scheme including competitive employer’s contribution
• Private Medical Insurance package with additional medical cash plan scheme
• Enhanced maternity and paternity pay
• Life assurance
• Free electrical car charging points
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and rail)

Pay

Salary: £30,000 – £35,000 DOE

Schedule

Full-Time; 12-month Fixed Term Contract