Regulatory Affairs Officer – Rapidly-Growing Scientific Business 

2 days left

Location
Camberley, Surrey
Salary
£30,000 Plus Benefits
Posted
26 Sep 2018
Closes
24 Oct 2018
Ref
HKPWY0711/GW
Contract Type
Permanent
Hours
Full Time

Regulatory Affairs Officer – Rapidly-Growing Scientific Business 
Camberley, Surrey 

The Company

Our client is a leading developer and manufacturer of diagnostic products. Their clinical product range supports healthcare providers in improving patient health, whilst their comprehensive food diagnostic range helps manufacturers ensure consumer safety. 

Having experienced record-breaking sales growth, they have exciting plans on the horizon and are looking for a Regulatory Affairs Officer to ensure their compliance as their success continues. 

The Benefits 

- Salary of circa £30,000
- Life assurance 
- Private medical insurance 
- Group pension scheme 
- 25 days’ annual leave plus opportunity to buy and sell leave 
- Cycle to work scheme 
- Refer a friend scheme

Operating at the cutting-edge of the medical device sector, our client is an innovator in every sense of the word. From the products that they make to the people they employ, innovation runs through the heart of the business. 

Our client has been striving to make the world a better place since day one. Back in 2009, they developed the world’s first swine flu detection kit, which is now being used in more than 30 countries across the globe. In 2013, they played a part in uncovering the meat adulteration scandal by measuring horse meat in food.  

Since then, our client has grown significantly, experienced substantial success and acquired a business specialising in infectious diseases, making them a force to be reckoned with in the scientific field. 

So, if you want to support the success of a business that’s striving to change the world for the better, one great idea at a time, our client would love to hear from you. 

The Role 

As the Regulatory Affairs Officer, 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 
- Assist with regulatory issues, recalls and corrective actions 

About You 

To be considered as a Regulatory Affairs Officer, you will need experience of the following: 

- Maintaining technical documentation for CE marked products 
- ISO 13485, ISO 9001 and EC certification 
- Completing regulatory submissions to support global product registration of medical devices 

Ideally, you’ll also have an HNC or higher qualification in a scientific discipline, but this isn’t essential. 

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 Officer, please apply via the button shown. This vacancy is being advertised by Webrecruit. The services advertised by Webrecruit are those of an Employment Agency.