2 days ago

Senior Regulatory Affairs Specialist

Enovis

Brisbane

2 days ago

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Enovis is seeking an experienced Senior Regulatory Affairs Specialist to join its global Regulatory Affairs team in Brisbane, Australia. The role involves developing and executing regulatory strategies for orthopedic medical devices, software, and AI-enabled technologies, and leading submissions for FDA, EU MDR, and TGA. The ideal candidate has 5+ years of experience in medical devices and strong knowledge of FDA regulations, EU MDR, ISO 13485, and ISO 14971.

AI-enabledOn-siteFull-timeSeniorRegulatory AffairsFDA 510(k)

Senior Regulatory Affairs Specialist

Apply

AI-enabledOn-siteFull-timeSeniorRegulatory Affairs

Salary

Not specified

Work Location

Brisbane, Queensland, Australia, AU

Work Model

On-site

Experience Required

5 years

Employment Type

Full-time

Experience Level

Senior

Core Qualifications

Technical (Must-have)

Regulatory AffairsFDA 510(k)EU MDRTGAISO 13485ISO 14971Medical DevicesSoftware as a Medical Device (SaMD)Artificial IntelligenceMachine LearningRisk ManagementClinical EvidenceLabelingPost-Market SurveillanceCAPA

Soft Skills

CommunicationAnalyticalProblem-solvingCollaborationIndependence

Preferred Qualifications

Technical (Nice-to-have)

TGA experience

Key Responsibilities

•Develop and execute regulatory strategies for new and existing medical devices and software.
•Lead and support regulatory submissions, including FDA 510(k), EU MDR technical documentation, and TGA submissions.
•Work closely with Engineering, Clinical, Quality, and Product Development teams throughout the product lifecycle.
•Provide regulatory guidance on product development, risk management, clinical evidence, testing, labeling, and product changes.
•Interact with FDA, Notified Bodies, and TGA and support pre-submission meetings.
•Support post-market activities, regulatory assessments, audits, CAPAs, and product changes.
•Help develop regulatory strategies for emerging technologies, including AI and machine learning.
•Monitor regulatory changes and advise the business on new requirements.

Regulatory AffairsMedical DevicesOrthopedicsDigital HealthAIMachine LearningFDAEU MDRTGASenior

Core Qualifications

Technical (Must-have)

Soft Skills

CommunicationAnalyticalProblem-solvingCollaborationIndependence

Key Responsibilities

•Develop and execute regulatory strategies for new and existing medical devices and software.

•Lead and support regulatory submissions, including FDA 510(k), EU MDR technical documentation, and TGA submissions.

•Work closely with Engineering, Clinical, Quality, and Product Development teams throughout the product lifecycle.

•Provide regulatory guidance on product development, risk management, clinical evidence, testing, labeling, and product changes.

•Interact with FDA, Notified Bodies, and TGA and support pre-submission meetings.

•Support post-market activities, regulatory assessments, audits, CAPAs, and product changes.

•Help develop regulatory strategies for emerging technologies, including AI and machine learning.

•Monitor regulatory changes and advise the business on new requirements.