Regulatory Affairs Associate

Up to £35,000 DOE
16 May 2019
13 Jun 2019
Dan Kilshaw
Contract Type
Full Time
Regulatory Affairs Associate  
Camberley, Surrey  

The Company 

With over 20 years of expertise, our client is a leading provider of high-quality diagnostic products. Their innovative offering enables healthcare providers to improve patient health and supports food manufacturers to ensure consumer safety.

They are now looking for a Regulatory Affairs Associate to join the team in Camberley and ensure compliance within a highly regulated environment. 

The Benefits 

- Salary of up to £35,000 DOE
- 25 days’ annual leave 
- Ability to buy and sell annual leave 
- Cycle to work scheme 
- Refer a friend scheme 
- Life assurance 
- Private medical insurance 
- Group pension scheme 
Always focusing on the wellbeing of their associates, our client consistently fosters a culture of support and focus on wellbeing; with impressive Summer and Christmas social events and a personal trainer visiting the office twice a week, you can be assured that you are valued from day one.

Joining our client’s dedicated and professional team, you will discover that their environment is one of innovation and creativity where exciting new products are developed, and boundaries are pushed. You will play a vital role in this process by ensuring that new products are compliant and can be taken to market. 

You’ll be encouraged to voice your ideas and support continuous improvement to make sure that your working environment is the best it can be, processes are efficient and best practice is followed every time. 

If this sounds like the kind of place where you can forge a career to be proud of, this is the role for you. 
The Role 

As the Regulatory Affairs Associate, you will take responsibility for our client’s technical documentation for their range of IVD products and ensure regulatory requirements are met. You will also manage regulatory submissions to support global product registration. 

Ensuring compliance with 98/79/EC and other regulatory requirements, you will update and maintain documentation and compile dossiers, submissions and responses to worldwide product registrations. 

Additionally, you will: 

- Provide full support to registration activities and regulatory submissions 
- Liaise with other teams throughout the business regarding applications for regulatory approval 
- Maintain your knowledge of significant developments in regulatory requirements and guidelines 
- Develop and maintain information on worldwide regulatory requirements and the status of product registrations 
- Work with local affiliates, distributors and agents 
- Assist with regulatory issues, recalls and corrective actions 
- Act as a knowledgeable resource for regulatory affairs across the business 

About You 

To be considered as a Regulatory Affairs Associate, you will need: 

- At least five years’ experience in maintaining technical documentation for CE marked products 
- Experience with ISO 13485, ISO 9001 and EC certification 
- Experience of completing regulatory submissions to support global product registration of medical devices 

Other organisations may call this role Regulatory Affairs Officer, Submissions Officer, Technical Documentation Co-ordinator, Regulatory Affairs Co-ordinator, Product Registration Officer, or Medical Device Registration Officer. 

Webrecruit and our clients are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be. 

So, if you are excited about becoming our client’s next Regulatory Affairs Associate, please apply via the button shown. This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.