Regulatory Life Cycle Specialist

Job Summary by the careerbalance.co.uk Team:

114Job Description:

Regulatory Life Cycle Specialist

Location: Sheffield + 2-3 days near Reading

Job Type: Full time, Permanent 

Salary: Up to £35,000/ year

Job Description

We are proud to be supporting this exciting and rapidly expanding organisation in finding a Regulatory Life Cycle Specialist to join their team.

To start, this position will require the successful candidate to work near Reading 2 to 3 days per week (fully expensed). This is to work on one of Company sites for 12 to 18 months.

As a Regulatory Life Cycle Specialist, you will report directly to the Quality Assurance and Regulatory Co-Ordinator.

Following identified regulations and standards for the region of UK and Ireland, you will execute regulatory assurance activities associated with maintaining product life cycle compliance.

The immediate focus of this role will be to support and work with a company that produces blood grouping reagents and blood transfusion solutions. Therefore, the position does require the successful candidate to write and review device compliant documentation for submission, in accordance with EU regulations (MDR-IVDR), standards and guidelines.

Essential duties and responsibility will include:

• Compilation of appropriate technical documentation and STEDS
• Review of submission documentation for compliance with appropriate regulations, standards and guidance.
• License and registration submissions according to regional requirements
• License and registration renewals
• Managing and reporting on submission deadlines and progress
• Submitting information and responding to queries from MOH bodies
• Reviewing significant product and process changes
• Maintaining and collating appropriate PMS/PSUR data

From the Sheffield site you will be responsible for the establishment and collation of plant data for management review and regular plant performance monitoring, as well as QA document collaboration

From the Reading site you will be responsible for document collaboration, batch history sign off, filing and archiving.

Required experience/ qualifications:

• The successful candidate will have excellent data management skills, and will be accurate and thorough with regards to quality management.
• You will have sound working knowledge of IT software including MS Office – Excel, Word and PowerPoint in order to present work.
• You will also have excellent written communication skills to check documents for errors in spelling and grammar and, that the numeric data is presented effectively.
• You will be able to vary writing processes, dependent upon needs and write in an informative manner.
• You will have excellent analytical skills to collect and analyse data, designing work flows and procedures to Identify data relationships and dependencies and, synthesize complex or diverse information.

In return the role is paying a salary between 32K and 35K, fully expensed for the work carried out near Reading for 2 to 3 days per week.  25 days holiday plus Bank Holidays and pension scheme and access to health and well-being benefits.

If your experience matches the requirements of this role and you’re looking for a position with a company that really values and invests in their workforce, APPLY NOW! Immediate start for the right candidate. 

Location: Sheffield, South Yorkshire