Regulatory Affairs Coordinator

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.

Let's talk about 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.

Let's talk about Job Environment:

• ResMed's products must comply with the regulatory requirements applicable to medical devices for the markets in which they are sold. This includes, but is not limited to, the Food and Drug Administration (FDA) in the United States of America, the relevant competent authorities in Europe and the Therapeutic Goods Administration (TGA) in Australia, as well as applicable international standards such as ISO 13485. ResMed products are marketed based on a reputation of high-quality standards for workmanship, performance, and reliability.

• The QA and RA Departments located at various operating units around the world are required to ensure that management systems are established to enable ResMed to comply with, and be able to readily display their compliance with, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer's quality requirements. In addition, the business must continuously improve its systems and processes. The application of a consistent, data driven methodology for process improvement across the company is required to optimize process efficiency and effectiveness.

Let's talk about Qualifications and Experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• 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!