ABOUT ENOVISTM
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .
Who We Are
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .
ABOUT ENOVISTM
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit .
What You'll Do
At EnovisTM we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence — with the goal of transforming medical technology as we know it.
Because that's how we change the lives of patients for the better. And that's how we create better together. Why work at Enovis? See for yourself
As a key member of the Regulatiry Affairs team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Job Title
Senior Regulatory Affairs Specialist
Location
Brisbane, Australia
Job Title/High Level Position Summary
We are seeking an experienced medical devices regulatory affairs professional to develop and execute regulatory strategies and manage product submissions for enabling technologies in the orthopedic industry. This role will be working on hardware and software as a medical device (SaMD) products for distribution as the Senior RA Specialist.



This role will develop and champion regulatory strategies, work within cross-functional teams, liaise with regulatory authorities to support the initial launch of medical devices. This role will also facilitate regulatory strategies which support use of machine learning and artificial intelligence within enabling technology products portfolio.
The Senior RA Specialist is responsible for managing regulatory activities within the United States, European Union and Australian markets. This role ensures compliance with Therapeutic Goods Administration (TGA) regulations, EU MDR ISO *****, ISO *****, 21 CFR 820 and company-wide quality standards. Working as part of a global RA function, the role will also support in sustainable regulatory activities such as management of postmarket surveillance activities on behalf of legal manufacturers, completing regulatory impact assessments for product changes and providing other regulatory SME support to the business as needed.
Key Responsibilities
Regulatory Affairs
Develop global regulatory strategies for new product development initiatives, identifying streamlined and least burdensome pathways for marketing authorization of new or modified products
Suggest and lead pre-submission meetings with FDA, Notified Body and TGA as determined to be necessary for select product development pathways
Partner closely with clinical affairs in development and execution of clinical strategy and necessary clinical investigations and evaluations related to achieving marketing authorizations
Act as regulatory representative on product development teams, providing regulatory input to the PDE/project manager on all facets of regulatory compliance, including but not limited to predicate identification and comparison, verification and validation testing, risk management, standard and common specification conformance, current trends in thinking and decisions by regulatory authorities
Execute regulatory strategies by preparing submissions and technical documentation for product approvals in the US, EU, and Australia. This includes responding to requests from reviewers and resolving deficiencies in submissions.




Partnering with Corporate Market Access team to coordinate and support select international registrations and maintain existing licenses and certifications through renewals
Act as regulatory SME during technical documentation audits
Perform regulatory assessments on product or process changes and execute necessary actions such as appropriate notifications, new 510ks, letters to file, technical file updates, license amendments, etc.
Review and approve QMS change orders, design change orders, and NCRs, ensuring changes don't impact safety and effectiveness of products without appropriate regulatory actions being taken
Review labeling and marketing collateral to ensure compliance with regulations, approval conditions, and consistency of any claims with appropriate data
Own and manage specific regulatory-related CAPAs, driving root cause investigation, implementation of actions, and confirming effectiveness
Support completion of HHEs and work the Corporate Shared Services team to manage field actions and recalls
Monitor industry-applicable regulations, guidance, standards, and common specifications for new or modified requirements; support initiatives associated with compliance with current or modified requirements
Maintain regulatory metrics for reporting to management, monitoring effectiveness of regulatory processes and ensuring accountability to internal and external stakeholders
Participates in the review of engineering specifications and quality programs in response to adverse quality levels or return trends.
Business Collaboration
Partner with Sales, Operations, and other functions to provide practical QA/RA guidance.
Review marketing, training, and educational materials to ensure compliance in all geographies
Work with cross-functional teams to ensure projects and initiatives meet regulatory and quality requirements.
Align local RA activities with global policies and standards.
Qualifications, Skills & Experience
Bachelor's degree in science, biomedical engineering, regulatory affairs, or a related field.
5+ years' experience in medical devices, healthcare, or related industry is desirable.
Proven skills in preparing regulatory submissions in the US, Europe and TGA (510(k), Technical Documentation and Conformity Assessments). Experience with international regulatory submissions is a plus.
Experience in working on products with machine learning and/or artificial intelligence is a plus
Expertise in US, EU and TGA regulations, ISO *****, ISO *****, and MTAA Code of Practice.
Ability to work independently within
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📌 Senior Regulatory Affairs Specialist (Queensland)
🏢 Enovis Healthcare Solutions
📍 Queensland