Careers

Regulatory Affairs Manager

We are recruiting for a permanent, full-time Regulatory Affairs (RA) Manager to join our Brisbane based team reporting to the General Manager. The RA Manager will own the regulatory strategy
for our medical devices, prepare and submit market authorisation applications and ensure continued compliance through post market surveillance. The role will suit someone willing to both take responsibility for the regulatory approval of our medical devices and actively contribute to the preparation of the underpinning documentation. Primarily based in our Northgate office, this role can include some remote and flexible work arrangements.

In this exciting growth phase, the RA Manager role will directly contribute to our success as we commercialise and deliver market-disrupting medical devices.

The primary responsibilities and activities of the role are:

• Developing premarket regulatory strategies for current and future medical device products and markets;
• Preparing and processing national and international marketing authorisation applications for magnetic resonance equipment;
• Managing the responses to regulatory submissions;
• Leading and undertaking postmarket surveillance and compliance activities;
• Identifying need for amendments and renewals of regulatory approvals;
• Maintaining the portfolio of regulatory documents and managing their update and review;
• Collaborating with Magnetica’s domain experts to ensure the accuracy and currency of the regulatory portfolio throughout the product lifecycle;
• Supporting product development including review of product technical developments and project matters against regulatory requirements;
• Being the primary liaison/point-of-contact for day-to-day matters in relation to Magnetica’s Authorised Representatives and regulatory authorities in jurisdictions where
  product will be marketed; and
• Other duties as agreed with the CEO or GM from time-to-time.

Your experience and qualifications to meet the requirements of the role will include:

• 5+ years of Regulatory Affairs experience within the medical device industry;
• Experience in at least one successful 510(k) preparation and submission;
• Demonstrated knowledge of US FDA regulations and guidance documents;
• Proven leadership and communication skills at both a strategic and operational level both internally and externally;
• Relevant qualification(s) in field(s) of Biomedical Engineering, Engineering and/or Biotech/Medtech or equivalent regulatory experience;
• Experience of working within an ISO 13485 accredited and/or 21 CFR Part 820 compliant organisation through certification and recertification cycles;
• Australian citizen, permanent resident or existing holder of appropriate visa to be able to work and live in Australia.

Other experience that will enhance your application includes:

• Demonstrated knowledge of EU MDR / AU TGA/ NZ Medsafe regulations and guidelines;

Your personal qualities will include:

• Accuracy, attention to detail and a focus on task completion (a finisher);
• Being self-driven with good time management and prioritisation skills;
• Good verbal and written communication skills across all levels of the business;
• The ability to successfully collaborate with technical and non-technical staff;
• A willingness and ability to take on non-core tasks to support team goals;
• A flexible approach to dealing with changing priorities and demands; and
• A history of safe work practices.

If this role sounds like a good fit with your capabilities and experience, please send your resume and a cover letter that addresses the criteria listed above to enquiries@magnetica.com.