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May

Regulatory Affairs Specialist – Medical Devices

David Penn Consulting P/L - Double Bay, NSW

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

We are searching for a new member to join our innovative team in Double Bay, Sydney NSW.

We are a dynamic and energetic team of healthcare and engineering professionals who design, develop and manufacture niche medical devices, mainly in the fields of Dentistry and Oral Medicine. We then sell our devices throughout the world via our own retailers and selected distributors. 

With our product mix rapidly expanding, and we are searching for an experienced individual to manage our Regulatory Affairs within a number of global jurisdictions. You would be managing medical device already in the market and all new devices currently in development and in the future.

This will be a hand-on role and you will need to hit the ground running and bring your breadth of experience to the role. The role will begin as a Part-time position for 3 days per week.

You must be authorized to work and permanently live in Australia before applying for this role. To be considered for this role, your Application must be supported by a cover letter outlining how your experience and skills match this role.

Key responsibilities of the role will be:

  • Ensuring compliance across the entire organization with our QMS and procedures.
  • Maintain all official authorizations, domestic and foreign, including certifications (such as TGA, CE & CA, FDA e-establishment & product listing).
  • Provide regulatory assessment/guidance of new product introductions.
  • Provide regulatory advice and operational support, for in market products, products ready for market and needing regulatory approval and new products.
  • Assisting with the preparation of regulatory submissions for FDA, TGA, Canada, CE and CA (UK).
  • Work directly with our international regulatory consultants where required to register products and submit applications. In time, we expect you will eventually manage the submission of applications for new medical devices.
  • Communicate clear and balanced regulatory risk assessments to internal stakeholders and business partners.
  • Acting as the main point of contact with TGA, FDA, Canada, CE and CA (UK).
  • Working with the local and global team to actively develop and implement effective procedures & guidelines.
  • Co-ordinate preparation and revision of product packaging artwork.
  • Provide regulatory support during pre-approval inspections, regulatory agency inspections, QP audits, cGMP audits and due diligence visits.
  • Complete gap analysis on registration dossiers to ensure they comply with government regulations prior to submission.
  • Assist with preparation, review and approval of controlled documents (e.g. Standard Operating Procedures, Technical Master File).
  • Maintain dossier compliance through change control assessment, provision of regulatory advice and submission of post-approval changes.
  • Participate in continuous improvement projects;

 Requirements:

  • Degree preferred in any the following disciplines: Biological sciences, dentistry, pharmacy, nursing, life sciences.
  • 5+ years regulatory affairs experience in Australia/USA/Europe working in an in-house compliance function.
  • Experience setting up a QMS and have successfully managed an ISO 13485 Audit.
  • Possess excellent verbal, written communication, presentation and time management skills.
  • Have outstanding interpersonal skills to ensure you fit into our dynamic team.
  • Be detail oriented, with a high degree of professionalism, diplomacy, discretion, and judgement.
  • Have the ability to work independently while also being a team player.

The right candidate must be able to display above skills and experience.

The position is immediately available.

To apply, please submit your CV together with a cover letter to demonstrate how your skills and experience align with our team. Your application must contain a cover letter.

Double Bay, NSW

Health, Medical & Pharmaceutical




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