Regulatory & Quality Manager – medical device company

Posted: 7 March 2022

The Client

The client is an Australia based medical device company specialising in wearable nasal technology as a novel way to address problems with breathing, sleep, nasal congestion, diagnostics and nasal drug delivery. Their existing CE Marked, FDA and TGA registered nasal products have been worn comfortably and safely since 2016. They continue to invest in product development with our product pipeline now extending to point of care diagnostics and nasal drug delivery internationally.

The Opportunity

As their new Regulatory & Quality Manager, you  will work with a highly motivated team to support the timely release of their nasal swab technology to markets, both domestically and internationally. You will be hands on and agile in changing your focus, with the ability to deal with ambiguity and change as our client rapidly undergoes expansion.

  • Develop and implement regulatory and clinical strategies to support existing medical device products and to assist in the commercialisation of new products
  • Manage product regulatory approval projects for the registration/inclusion of their medical devices in global markets
  • Liaising directly with the Australian TGA, FDA, EU Notified Bodies and international regulatory authorities
  • Implement and maintain a QMS in accordance with ISO13485 and the US Code of Federal Regulations 21 CFR Part 820.
  • Manage improvement processes within the QMS including CAPA, non-conforming product, quality audits, complaint handling, change control and other improvement processes.
  • Promote awareness of regulatory and quality management system requirements throughout the organisation providing guidance and advice as required,
  • Liaising with third party manufacturing sites and other suppliers to ensure quality compliance
  • Leading Post-Market Surveillance and Post-Market Vigilance activities
  • Integration with the product development team to provide regulatory input into product development
  • Maintaining product technical files and working with partners to provide the technical documentation they require to integrate their products into their product offering.
  • Keeping up to date with international legislation, standards and guidelines in all countries.
  • Ensure continued regulatory compliance for all aspects of manufacturing and production.

Position Requirements

  • 5+ years’ experience in a quality and regulatory role in the medical device industry.
  • Expert knowledge in medical device regulations and quality management standards such as 21 CFR 820, MDR/MDD, IVDR/IVDD, ISO 13485, ISO 14971.
  • Demonstrated experience in taking multiple products to market including regulatory approval.
  • Demonstrated experience in influencing business decisions to align to quality standards.
  • Degree qualifications in science, engineering or equivalent.

The Offer

Our client offers an exceptionally dynamic and progressive work environment. This fulltime or part time role is at the frontline of development of new innovative technologies. They expect, and provide, excellent professional standards and work ethics. As a valued member of this team, you will have the opportunity to demonstrate your talent and shape this new and exciting company.  This role is a pathway into the business offering professional growth and development opportunities for the right candidate.

To join our client in this exciting opportunity please email your cover letter & CV to careers@mexec.com.

Confidential enquiries to Marilyn Jones on 1300 0 MEXEC.

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