About Navbit

Navbit is an Australian surgical technology innovator and manufacturer, founded by surgeons to solve complex technical challenges in orthopaedic surgery. The company applies emerging high-performance sensor technologies to the surgical workplace, combining innovation with rigorous regulatory and quality standards. Its flagship products, Navbit Sprint and Navbit MARQ, are affordable hip alignment devices, while Navbit Rapid Surgical Plan delivers preoperative spino-pelvic alignment information to surgeons.

All Navbit products hold clearances from the Australian TGA, CE Mark, and FDA, reflecting strong global regulatory compliance. Navbit also maintains dual certification to ISO 13485 and the Medical Device Single Audit Program (MDSAP), underscoring its commitment to quality and international standards. Roles (2 - 3 days per week)

Support engineering change control processes to Navbit’s products, assisting in change management planning and implementation. Determine regulatory impact and submission/notification requirements, including preparation of significant/non-significant change assessments.

Prepare and submit regulatory/change notifications and coordinate regulatory reviews with Notified Bodies, Competent Authorities, regulatory agencies, in-country representatives and distribution partners. Preparation, review, and maintenance of regulatory submissions and registrations for global markets, ensuring regulatory documentation is accurate, complete, traceable, and compliant with applicable regulations.

Create and maintain Unique Device Identification (UDI) records - Basic UDI-DI and UDI-DI - and associated registry entries, including EUDAMED, US FDA GUDID and the Australian (TGA) UDI database, as applicable.

Support and maintain required establishment registrations and device listings in each country/region,



including coordination of supplier and actor linkages.

Liaise with Authorised Representatives and other regulatory/actor representatives across multiple global markets. Manage regulatory correspondence, questions, and responses within agreed timelines.

Own and manage post-market surveillance and vigilance activities, including PMS planning, PMS reports, PSUR preparation, complaint trending input, regulatory reporting assessments, adverse event reporting, Field Safety Corrective Actions (FSCA), recalls, and regulatory authority communications.

Support ongoing clinical evidence, including Post-Market Clinical Follow-up (PMCF), clinical evaluation updates, and real-world evidence activities to ensure continued regulatory compliance.

Maintain regulatory intelligence, monitor changes and maintain state-of-the-art for applicable regulations, standards, and guidance documents. Perform regulatory impact assessments and implement required updates to Technical Documentation, QMS procedures, and product compliance activities.

Prepare and maintain product labelling and review promotional materials to ensure compliance with applicable regulatory requirements. Maintain regulatory compliance throughout the product lifecycle. Identify regulatory risks and provide mitigation strategies to cross-functional teams.

Maintain accurate regulatory records and documentation within the QMS including Product Technical Documentation, Essential Principles,



and General Safety and Performance Requirements.

Support

Navbit audits including internal, suppliers and external audits and regulatory inspections.

Support the Person Responsible for Regulatory Compliance (PRRC) in fulfilling regulatory compliance responsibilities under EU MDR 2017/745 Article 15, including technical documentation compliance, post-market surveillance oversight, and regulatory obligations.

Undertake additional responsibilities as assigned by management. Education:

Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, legal, Regulatory Affairs, or related discipline with a minimum of 5 years’ experience in medical device regulatory affairs, preferably supporting Class IIa or higher-risk devices.

Specialised

Knowledge

Working understanding of customer, quality and regulatory requirements for medical devices. Skills:

Strong written and verbal communication and interpersonal skills.

Attention to detail and accurate record-keeping.

Strong experience preparing and maintaining regulatory submissions and technical documentation.

Competent with document control and quality management system (QMS) processes. Abilities:

Communicate effectively, collaborate with others, solve problems and demonstrate high integrity.

Strong analytical skills.

Commitment to patient safety and regulatory compliance.

Strong decision-making capability and ability to prioritize competing activities.

Ability to work independently and communicate necessary information Experience:

5 years of professional experience in regulatory affairs relating to medical devices.

Experience with EU MDR 2017/745 Technical Documentation.

Experience with TGA, FDA, PMDA regulatory pathways.

Experience supporting Notified Body/Auditing Organisation/regulator audits.

📌 Regulatory & Compliance Lead. Medical Devices (Sydney)
🏢 Navbit
📍 Sydney