Job Description

• Working with the Regulatory and Quality Manager to ensure that company products, which are developed, manufactured and distributed meet the required standards and legislations.
• Working on regulatory projects such as the registration of PT1 and PT2 products under BPR transitional rules, preparing product dossiers and ensuring product labels are compliant with Article 69
• Submission of product data to competent authorities
• Medical Device Registrations
• Update and maintenance of Product Technical Files
• Assist with the implementation of UDI
• Collaborating with Regulatory, Labelling and Technical departments
• Keeping up to date with changes in regulatory legislation and guidelines
• Liaising with regulatory authorities
• Providing advice about regulations to R&D
• Completion of internal audits
• General departmental activities, as required

Additional pay:

• Bonus scheme

Benefits:

• Company events
• Work from home

Schedule:

• Monday to Friday

Required Knowledge, Skills, and Abilities

University degree in a science related subject (desirable). Experience of ISO13485 (desirable). Experience of quality management systems. Internal audit training. Knowledge of Biocides Regulation 528/2012. Knowledge of MDD 93/42/EEC & MDR 745/2017. Experience with product families and union authorizations.Experience: regulatory: 2 years (Required)