Our Story 4 DMedical is a cutting-edge medical technology company specializing in advanced diagnostic imaging solutions that revolutionize respiratory healthcare.
We are an ASX-listed company with products that are FDA-cleared/TGA-approved.
Utilizing our innovative four-dimensional imaging technology, we provide actionable insights into lung function, enabling early detection and precise treatment of respiratory conditions.
Complementing our approach, we also develop sophisticated AI-driven lung imaging analysis to enhance the accuracy and depth of diagnostic information.
Together, these technologies deliver a comprehensive suite of tools for personalized respiratory care.
Our team is dedicated to pushing the boundaries of medical science to enhance patient outcomes and drive the future of healthcare.
Join us at 4 DMedical and be part of a vibrant, forward-thinking company committed to making a significant impact on global health through technological excellence and innovation.
4 DMedical is committed to helping Veterans dealing with deployment-related respiratory diseases and toxic exposures (Burn pits).
Summary of the position The Regulatory Affairs (RA) Associate will be responsible for executing product submissions and maintenance of product regulatory status in any assigned geography according to the regulatory strategy set by the business.
This individual will play a critical role in product release activities, working closely with internal teams and external stakeholders to ensure regulatory product compliance.
This is an exciting opportunity for ongoing career progression and a chance to do regulatory work on cutting-edge Software as a Medical Device (Sa MD) and Artificial Intelligence.
Friendly collaborative team and 4 weeks holiday as well as other great USA-based benefits.
Responsibilities/Duties Implement regulatory strategies to support product development, registration, and commercialization in targeted markets.
Coordinate interactions with regulatory agencies, including preparation and submission of documentation, and responding to inquiries and requests for additional information.
Collaborate with cross-functional teams, including R&D, Clinical Affairs, Quality Assurance, and Marketing, to ensure regulatory requirements are effectively implemented during product development and marketing strategies.
Support the Director of Regulatory Affairs to negotiate with regulatory authorities to resolve any issues that arise during the product review and approval process.
Ensure that product labeling, marketing materials, and product claims are accurate and comply with regulatory requirements for their assigned products.
Execute the preparation and maintenance of regulatory submissions and documentation, including technical files, registration dossiers, and annual reports.
On direction from your Manager, assist other employees on specified projects or tasks, and conduct other activities that are necessary and appropriate for the successful operation of 4 DMedical.
Qualifications and Industry Experience Requirements: 4-year degree, preferably in a science-related discipline (e.g.
sciences, engineering, etc).
AND/OR Clinician with experience in clinical application of software use in the medical imaging field.
Master's degree in Business / Science or equivalent is a plus.
3+ years working with Software as a Medical Devices in Regulatory Affairs is essential.
FDA e STAR and Health Canada submission experience.
Experience communicating with cross-functional teams to support product development.
Demonstrated writing skills in the medical devices industry.
Intermediate proficiency in Microsoft Office suite.
Desirable: Basic understanding of human anatomy and physiology.
Regulatory Affairs Professionals Society (RAPS) medical device certificate OR certification.
How to apply Please apply via this link here and submit a current CV and a cover letter that details your alignment with the requirements of the role.
4 DMedical provides an inclusive work environment and embraces the diverse talent of its people.
People of all ages, genders, and backgrounds; including military service members and veterans are strongly encouraged to apply.
We are an Equal Opportunity employer, providing a dynamic, supportive work environment.
Successful candidates will be required to undergo background checks and credentialing, as well as provide documentation (e.g.
I-9 verification).
For more company information visit our website: Should you have any queries regarding the position please contact the 4 DMedical Recruitment Team at: .
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