Quality and Regulatory Analyst at Dexcom

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

19 Jun, 26

Salary

0.0

Posted On

21 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, ISO 9001:2015, Good Wholesaling Practice, Regulatory Frameworks, Internal Audit, External Audit, Pharmacovigilance, Device Vigilance, Regulatory Documentation, Product Registration, Legislation Review, Product Recalls, Corrective And Preventive Actions, TGA, Medsafe, Microsoft Office Suite

Industry

Medical Equipment Manufacturing

Description

About Australasian Medical and Scientific Limited (AMSL) and New Zealand Medical & Scientific (NZMS): AMSL and NZMS are subsidiaries of Dexcom, a worldwide leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. We form partnerships with world leading medical device, pharmaceutical and scientific innovators and are passionate about introducing and establishing advances in healthcare and science for the benefit of patients and healthcare providers. Working in the Medical Devices Industry, you will be exposed to a broad range of products that have life changing effects on a patient's quality of life. Meet the team: Join our dynamic and passionate team dedicated to making a difference in healthcare, specifically in the field of diabetes. Our Quality and Regulatory team is dedicated to ensuring the highest standards across our diabetes product portfolio. We work collaboratively across the organisation to meet all quality and regulatory requirements, from product launch and advertising through to post-market surveillance. Where you come in: You will coordinate tasks related to the Quality Management System (QMS), ensuring compliance with principal company requirements, Good Wholesaling Practice (GWP), and applicable regulatory frameworks, including implementation and maintenance of ISO 9001:2015. You will assist with the quality operations of our 3PL warehouse, ensuring compliance with local regulations and corporate standards. You will assist in developing and executing internal and external audit procedures to ensure continual compliance and quality improvement. You will manage all aspects of pharmacovigilance and device vigilance activities for AMSL and NZMS, ensuring timely reporting and compliance. You will review advertising and promotional materials to ensure alignment with local advertising codes and regulatory requirements. You will support the preparation and submission of regulatory documentation to obtain and maintain product registrations in Australia and New Zealand You will conduct reviews of relevant legislation and regulatory updates and manage product recalls in compliance with applicable codes/standards. You will support onboarding and training of new employees in QMS procedures and related areas. You will investigate and document quality issues and non-conformances, working cross-functionally to implement corrective and preventive actions. What makes you successful: You will have proven experience in developing and implementing ISO 9001:2015-compliant QMS. You have knowledge of medical device registration processes with both Medsafe (NZ) and the TGA (Australia). You have high attention to detail and strong analytical thinking. You have excellent organisational and time management skills. You have strong written and verbal communication. You are proficient with Microsoft Office Suite (Outlook, Excel, PowerPoint, Word). Travel Required: 0-5% Experience and Education Requirements: Typically requires a Bachelor’s degree and a minimum of 2-5 years of related experience To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.

Responsibilities

The role involves coordinating tasks related to the Quality Management System (QMS) to ensure compliance with company requirements, GWP, and regulatory frameworks, including managing pharmacovigilance and device vigilance activities. Responsibilities also include reviewing promotional materials, supporting regulatory submissions for product registration, and investigating quality issues to implement corrective actions.