Regulatory Affairs Administrative Assistant
2 weeks ago
Summary:
A Regulatory Affairs Administrative Assistant provides essential support to regulatory affairs professionals in managing compliance, documentation, and administrative processes. They play a crucial role in ensuring smooth operations within the regulatory department.
Responsibilities and Accountabilities:
Document Management: Assist in preparing, compiling, and maintaining regulatory documentation, including submissions, forms, reports, and records.
Communication: Handle administrative requests and queries related to regulatory matters.
Meeting Coordination: Schedule and organize meetings, including taking detailed minutes during regulatory discussions.
Filing System: Develop and maintain an organized filing system for regulatory documents, including updates to tracking systems.
Policy Updates: Assist in updating and maintaining policies and procedures related to regulatory affairs.
Liaison: Act as a point of contact for internal and external stakeholders regarding regulatory inquiries.
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.
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.
Minimum
High School degree: additional qualifications as an Administrative Assistant or Secretary are advantageous.
Proven experience as an Administrative Assistant, Virtual Assistant, or Office Admin Assistant.
Familiarity with regulatory processes and compliance requirements.
Working knowledge of software (MS Office, especially Excel and PowerPoint).
Excellent time management skills to prioritize work effectively.
Strong attention to detail for accurate documentation.
Excellent written and verbal communication skills.
Ability to multitask and maintain organizational efficiency.
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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