Job title: Regulatory Support

Location: Crigglestone, Wakefield

Department: Technical   

Reporting to: Technical Manager

Salary range: £ negotiable

Summary of position:

TSL is looking for Regulatory Support to continue supporting our growing private label & branded FMCG business, trusted by the biggest names in the UK and beyond, including Boots, Tesco, Superdrug and the NHS to supply self-care and active living solutions.

Due to a vacancy arising within the technical team, and the need to continue providing crucial Regulatory support to the technical functions of the business. You will work closely alongside the technical whilst reporting directly into the Technical Manager, to manage the technical files and any other regulatory compliance requirements.

It is important that you are a self-starter, self-motivated, not afraid to ask for help and confident in working from home in a new role. In return, you will benefit from a team who offers full support with an open culture.

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Primary responsibilities:

• Provide technical support to the business, suppliers and customers on all matters relating to the safety, legality and quality of the products purchased and sold:

• A clear understanding of the legal requirements for labelling and testing within the required product areas.
• To ensure all products comply with relevant legislation.
• Produce and maintain up to date technical files for medical devices to the required standards.
• Ensure all quality and technical issues relating to technical files are resolved effectively. Escalate when necessary to the Technical Manager.
• Assess device related incidents/complaints for medical device reporting requirements. When required, compile and submit reportable events to relevant regulatory authorities in timely manner.
• Review of complaint and other product related information in order to create annual Post Marketing Surveillance report.
• Stay abreast of regulatory procedures and changes in regulatory climate. Keep the business informed of changes in upcoming regulatory requirements that will impact on the business.

• Assist support to the Technical Support Manager / Product Technologist to aid the development of customer technical relationships to ensure that we are the trusted go to suppliers for our product range:

• Assist with customer and internal specifications are prepared on time that they are up to date and active to help ensure products are launched on time.
• Support the introduction of New products by advising on Regulatory requirements when appropriate.

• Support and assist the Technical Manager in managing any relevant quality and technical issues:

• Manages and resolves quality issues in a timely manner with clear solutions and communication to all relevant stakeholders.
• Perform Mock recalls as necessary.
• Support Technical Manager and Technical Director with adhoc projects and duties as required.

Competencies:

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Essential:

• Experience in Technical files and Post market surveillance
• Expert knowledge of MDD/MDR, ISO13485

Desirable

• Experience of working to cGMP
• Expert knowledge of BRC, HACCP, cosmetic regulation, REACH or PPE regulation
• Experience of NCR / Deviation Investigations.
• Experience interacting with Notified/Approved Body

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To find out more about TSL, please visit www.tslhealthcare.com or check out our LinkedIn profile