We are a designer and manufacturer of patient-specific dental prosthetic solutions. Within the dental industry we have pioneered fields of engineering to create some of the most advanced dental prosthetics in the market. We take pride in innovation, technical excellence and superior product design and manufacturing.
Osteon Medical is seeking a detail-oriented and proactive QARA Specialist on a 12-month parental leave contract to ensure the quality and regulatory compliance of our products. This role is pivotal in managing quality systems, regulatory submissions, and driving continuous compliance improvements throughout the product lifecycle—from design to post market surveillance and support.
Key Responsibilities
* Improve, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485 and relevant regulatory requirements (e.g., EU MDR, TGA, PMDA).
* Prepare, review, and submit regulatory submissions for new product approvals and registrations, and maintain the existing registrations and database entries.
* Manage and assist with internal and external audits, and address non-conformances.
* Lead the investigation and resolution of nonconformities and customer complaints, and CAPAs as per defined procedures.
* Monitor regulatory changes and provide actionable guidance to maintain compliance.
* Manage changes related to the products and the QMS according to the defined Change Control Process.
* Collaborate with cross-functional teams to ensure compliance with regulatory requirements during throughout the product lifecycle from product development and to post-market activities.
What We’re Looking For
* Bachelor’s degree in Engineering, Biomedical Sciences or a related field.
* ISO 13485:2016 Internal audit / Lead auditor certification is a plus.
* Experience in QARA roles for medical devices (Class I or II).
* Proficiency in ISO 13485 and/or global regulatory frameworks (e.g., FDA, EU MDR, TGA).
* Expertise in managing NCs, customer complaints, and CAPAs, including root cause analysis and implementing effective corrective actions.
* Strong organisational, problem-solving, and communication skills for effective collaboration with regulatory bodies and internal teams.
Why Join Us?
At Osteon Medical, we are solution-obsessed, team-driven, and constantly pushing the boundaries of innovation in the tech and dental spaces. Join our dynamic team and contribute to shaping the future of dental hardware solutions in a collaborative and supportive environment.
So join us now. Click on the Apply to start the conversation!
Seniority level
Entry level
Employment type
Full-time
Industries
Medical Equipment Manufacturing
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