Aug 03, 2021

Regulatory Affairs Officer

  • Metix Ltd
Full time Regulatory

Job Description

Metix is an established and successful medical technology company that is currently developing the next generation of medical devices that have the potential to improve medical care in pre-hospital care settings. We are looking for a Regulatory Affairs Officer to join our team.

This role will help support the COO to implement the organization's regulatory affairs strategy, in order to fulfill the company's commercial strategy. The role requires an understanding of the current FDA regulatory framework and processes, in order to progress documentation, support submissions and maintenance of medical device data.

Key areas of responsibility:

  • The maintenance of Technical Documentation Files.
  • Administrate regulatory dossiers to support product license applications, import license and product license maintenance for Regulatory Authorities.
  • Maintain specialist knowledge and tracking of the regulatory requirements within each of the operational geographical territories.
  • Support for the development of the company's regulatory planning, incorporating strategies for the product range in accordance with global requirements.
  • Support product risk management activities and the life-cycle of marketed products.
  • Support for the post-market surveillance, preparing reports for the product range.
  • Support the regulatory requirements of the product development process, contributing to product validation plans, reports, claim support papers and other post-market activities.
  • Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and other regulatory requirements as identified.

Qualifications & Experience:

  • Degree qualified preferably in a life science and experience working within a regulatory affairs arena.
  • Knowledge of ISO 13485, FDA 21 CFR 820 and FDA submissions
  • Excellent organizational skills and an ability to work to tight timelines.
  • Demonstrate strong team skills.
  • Proficient in the use of IT, including Microsoft Office suite and Electronic Document Management systems.
  • Excellent communication skills when liaising within the company and with external customers.

Benefits

This position in a multi-award-winning Medtech company is challenging and rewarding at the same time. You will be working in a flexible multi-cultural environment, under the supervision of the Quality and Regulatory Affairs Manager. You will interact with technical teams internationally either remotely or in person. The current company structure allows for fast professional growth for exceptional performers.

Additional Benefits:

• Flexible working hours

• Relaxed working environment

• Short walking distance from Glasgow Central Station

• Casual dress code

• 35-hour contract with an hour lunch

For further information on Metix, please visit our site: www.metixmedical.co.uk or follow us on Twitter: https://twitter.com/MetixMedical/

The successful candidate must have permission to work in the UK by the start of their employment


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