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  • jobs
  • 1 month ago

jobs description

A hybrid role working across both Quality and Regulatory Affairs, building processes suitable for a fast-growing company, partnering to accelerate innovation and R&D, and maintaining standards for current products. The ideal candidate will be based in either the United Kingdom or Ireland.

The role requires a broad understanding of regulatory requirements across multiple legislations and geographies. It also requires an understanding of working within a QMS framework to support multiple product types and classifications.

Key Responsibilities

Quality:
• Ownership of supplier control process, including creation and implementation of supplier review cycles e.g. Quality Technical Agreements, audit schedules.
• Leading external audits and driving associated actions to completion.
• Creating and managing CAPA, NC, change control, including conducting investigations to drive root cause.
• Ensuring Quality System processes are lean, compliant, user-friendly and are well understood... throughout the organisation.

Regulatory:
• Technical File creation and maintenance for Class I and II devices to MDR and UKCA.
• Medical device dossier submissions and liaison with NB’s and HA’s.
• Working in partnership with R&D in new product design and modifications/line extensions.
• Performing post market surveillance activities including clinical follow up and periodic safety reports.
• Defining regulatory strategy for domestic and international markets.
• Ensuring compliance where applicable to relevant domestic and international standards e.g. ISO 13485, MDD 93/42/EEC, FDA CFR 21, MDR EU 2017/745 and UK MDR 2022 SI 618.

Cross functional:
• Provide expert guidance, support and training on quality and compliance matters to the functional teams.
• Enhance a compliance culture throughout the organisation.
• Carry out training and communication activities with staff to ensure adequate understanding of quality systems and regulatory requirements.
• Drive continuous improvement and best practice.

Person Specification

Requirements:
• Life Sciences / Regulatory Sciences degree.
• Experience of working as a Quality Professional.
• Experience of working as a Regulatory Professional.
• Experience working with medical devices either in a quality or regulatory role.
• Experience of working within and managing a quality ISO framework e.g. ISO 13485, ISO 9001.
• Experience of working with / within MDR.

Desirables:
• Experience with licenced medicines in the UK or EU.
• Experience with ophthalmic products in the US.
• Experience with cosmetics and food supplements.
• Experience with sterile products.
• Experience of creating / maintaining clinical evaluation and biological evaluation reports.
• Lead auditor (external
United Kingdom

salary-criteria

Apply - Quality Assurance Regulatory Affairs Manager United Kingdom