Regulatory Affairs Coordinator

vor 1 Monat

Sydney, Österreich Resmed Inc Vollzeit

Regulatory Affairs CoordinatorApply locations Sydney, NSW, Australia
Time Type: Full time
Posted on: Posted Yesterday
Job Requisition ID: JR_035534
The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the preparation of regulatory documents, maintaining records, and coordinating with various departments to support product registrations and regulatory submissions.
Responsibilities and Accountability: Regulatory Submissions: Assist in the preparation of regulatory documentation for product registrations, amendments, and renewals in compliance with global regulatory requirements.
Document Management: Maintain up-to-date regulatory documents and ensure proper organization, tracking, and archival of submission dossiers, technical files, and other regulatory records.
Communication & Coordination: Collaborate within the RA departments to gather necessary information for regulatory submissions and maintain clear communication with regulatory agencies.
Post market Surveillance Support: Assist in coordinating post market activities such as adverse event reporting, field actions, and periodic safety updates in accordance with applicable regulations.
Regulatory Database Management: Update and maintain databases related to regulatory submissions, approvals, and compliance tracking.
Audits & Inspections: Provide support during regulatory audits and inspections, helping to prepare and organize necessary documents and reports.
Training & Documentation: Assist in developing and updating training materials on regulatory processes, ensuring company-wide awareness of compliance obligations.
Qualifications and Experience: Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field.
1-3 years of experience in regulatory affairs, preferably within the medical device, pharmaceutical, or biotech industries.
Familiarity with global regulatory requirements (e.g., FDA, EMA, Health Canada, TGA, etc.).
Proficient in regulatory submission processes, document management systems, and quality systems.
Strong organizational skills and attention to detail.
Excellent verbal and written communication skills.
Ability to work both independently and collaboratively in a fast-paced environment.
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now

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