Regulatory Affairs Officer
Regulatory Affairs Officer
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.
They are now looking for a Regulatory Affairs Officer to join the team in Camberley and ensure compliance within a highly regulated environment.
- Salary of circa £40,000 DOE
- 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
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.
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
- 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
To be considered as a Regulatory Affairs Officer, 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 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.