Regulatory Affairs Manager

2 weeks ago

Brisbane, Australia OnTalent Full time

Regulatory Affairs, submissions, compliance
- 13485, FDA, CFR and other regulations/guidelines
- MedTech product, complex systems

**About Magnetica**

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.

**Your essential experience to meet the requirements of the role will include**:

- Developing premarket regulatory strategies for current and future medical device products and markets.
- 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 existing capabilities and skills will include**:

- Proven Regulatory Affairs experience within the medical device industry.
- Relevant qualification(s) in field(s) of Biomedical Engineering, Engineering, and/or Biotech/Medtech or equivalent regulatory experience.
- 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.
- Experience of working within an ISO 13485 accredited and/or 21 CFR Part 820 compliant organisation through certification and recertification cycles.
- Demonstrated knowledge of EU MDR / AU TGA/ NZ Medsafe regulations and guidelines.
- Accuracy, attention to detail, and a focus on task completion (a finisher).
- 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 with a flexible approach to dealing with changing priorities and demands.

Confidential enquiries can be made to Peter Starling, Senior Client Partner, on 07 3305 5830.

magnetica

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