Senior QARA Specialist

Senior QARA Specialist

Smith & Nephew

Hoersholm, Denmark

Summary

This role will be immediately based in Hoersholm, before moving to our new commercial hub in Ørestaden, Copenhagen, later this year. The role will support our Commercial Quality and Regulatory Affairs function, applying knowledge and understanding of the necessary quality and regulatory frameworks. As part of the role we need expertise in the Nordics, supporting the warehouse and distribution activities, providing an understanding of medical device regulations, EU MDR and ISO 9001:2015.

Essential Job Functions

  • Support in Non-Conformance reports, Corrective Action Requests, change control actions and Quality Management Review, supporting ongoing design and maintenance of our quality systems and processes.
  • Manage internal audit schedule for relevant sites and perform internal and supplier audits as required.
  • Interacting with and liaising with Competent Authorities as part of field action, vigilance and post-market surveillance activities.
  • Manage and direct writing and review of regulatory processes and procedures to ensure compliance, efficiency and clarity.
  • Responsible for answering technical and regulatory enquiries from customers and/or colleagues to support their business activities (such as tenders submissions) and meet requirements.

Requirements

  • Ideally, a degree in Engineering or Life Sciences with the relevant QARA experience.
  • Fluent in English, Danish or Swedish is highly desired.
  • Knowledge of ISO 9001:2015.
  • Solid knowledge of Medical Device Directive, Medical Device Regulation (European Union Medical Device Regulation (EU) 2017/745 and knowledge of Goods Distribution Practice for medical devices.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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