Sector: Life Sciences
Consultant: Chris Hutchinson
Salary: £20000 - £30000
Job Status: Permanent / Full Time
We are looking for a highly organized individual with an eye for detail to help assist in our Regulatory Department
Ideally, some knowledge of this area either in a related field (i.e. Medical) would be preferable however the willingness to get involved, excellent organizational skills and the ability to adapt to a changing landscape would be seen as positives.
The main purpose of the role will be to:
- Assist in the management of the companies Regulatory requirements
- This includes but is not limited to:
- CE Certification, ISO Certification, Registration and Regulatory Control of Product
- Assist and facilitate product development and global registration through the efficient preparation and management of regulatory documentation, information, and systems.
- Maintain regulatory document management systems and tracking systems, maintain core Technical File components and be responsible for quality control of regulatory files, archive and tracking systems.
- Electronic document management of ongoing submissions and incoming and outgoing correspondence with both customers and Regulatory bodies’
Further responsibilities will include:
Archiving of regulatory submissions and correspondence
Day to day oversight of regulatory requirements within the business as well as management of individual projects and management of Regulatory Information Projects.
Administration of and reporting from regulatory registration audits and processes
In order to be considered for this role, the individual will be required to have the following and preferably have related experience in Regulatory Information Management.
Document Management Experience and ideally familiarity with regulatory processes and procedures.
Attention to detail, time and project management skills, good written and verbal communication skills, results orientated and proficient in MS Word, MS Excel and MS PowerPoint.
This role is offering up to £30,000 depending experience.