Location: Head Office (Wokingham UK)
Department: Design and Development
Salary: £25,000 - £27,000
Contract Type: Permanent
We are looking to recruit a detail-oriented and proactive Technical Labelling Coordinator who will be responsible for managing and overseeing labelling projects of Instructions for Use (IFUs) and related product labelling.
This role is critical in ensuring our Inspections for Use (IFU) comply with regulatory requirements, standards and internal specifications.
As a Labelling Coordinator, you will be responsible for coordinating Inspections for Use (IFU) reviews by key stakeholders, managing changes and approvals, and ensuring labelling content accuracy and regulatory compliance.
This position will be joining our thriving UK medical device manufacturing company to work within our Technical Department.
The successful candidate brings a strong understanding of regulatory documentation and a proven ability to coordinate document reviews by multiple stakeholders. This position requires strong organisational skills, attention to detail and the ability to maintain comprehensive records of changes and decisions throughout the Inspections for Use (IFU) lifecycle.
Essential Experience/Qualifications
* Qualification or degree in Science (Chemistry, Biology, Physics, Materials or a related subject) or relevant documentation experience
* Strong organizational skills and able to work effectively with cross-functional teams
* Able to manage documentation workflows and maintain detailed records of changes and decisions
* Able to function in a highly regulatory environment with a focus on compliance
Desirable Experience/Qualifications
* Experience in reviewing and evaluating technical and regulatory documentation for accuracy, compliance, and completeness
* Knowledge and understanding of regulatory requirements related to labelling and Inspection for Use (IFU) (e.g., FDA, EU MDR/IVDR, ISO 15223, ISO 20417)
Key Skills
* Able to gather, evaluate, critically interpret and communicate information
* Excellent verbal and written communication skills
* Able to build good working relationships
* Able to work well under pressure and meet deadlines
* Able to multitask and prioritise workload
* Able to work independently as well as within a team
* Able to work effectively across a number of interrelated departments
* Self-motivated
* Have a can-do attitude with an enthusiastic approach to work
* I.T. Literate – Microsoft Office
* Methodical, organised and structured approach to work
* Excellent attention to detail
Hours of Work
40 hours per week
Equal Opportunities
We are committed to creating a diverse and inclusive workplace for all. We are an Equal Opportunities Employer and welcome applications from all individuals, regardless of age; disability; gender; gender reassignment; marital or civil partnership status; pregnancy and maternity; race; religion or belief; sexual orientation, or any other characteristic protected by law. We believe that diversity enriches our workplace and enhances our ability to deliver exceptional results. We assess all applications based on skills, qualifications, and experience, ensuring a fair and equitable recruitment process.
**No Agencies please**
Benefits: Competitive Annual Leave Entitlement, Matched pension contributions with length of service Family feel company, Flexible working hours, Training and progression opportunities, Annual performance and salary review, Competitive annual leave entitlement, Generous Company contribution toward gym membership, Matched pension contributions with length of service, Cycle to Work Scheme
REF-(Apply online only)