Senior Regulatory Document Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000

Regulatory Affairs Specialist Job Description

Job Summary:

The Sydney RPSD team is seeking a Regulatory Affairs Specialist to lead global regulatory submissions, interpret device-specific requirements, and translate them into clear regulatory documentation.

Key Responsibilities:

  • Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.

  • Interpret device-specific requirements (e.g., ISO 17510, ISO 80601, ISO 18562) and translate them into clear, well-supported regulatory documentation.

  • Align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.

Product Change & Lifecycle Support:

  • Lead regulatory assessments of design and process changes—performing significance evaluations and preparing documentation updates.

  • Provide regulatory input on system-level verification, biocompatibility, human factors, and labelling updates for high-volume products.

  • Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance.

Cross-Functional Integration & Design Control Support:

  • Represent RA in cross-functional design teams for products under Sydney legal manufacturer scope.

  • Engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.

  • Act as a key point of contact for internal stakeholders on Sydney product regulatory requirements and interpretations.

Mentorship & Peer Enablement:

  • Mentor junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration.

  • Support onboarding and documentation standardization across the Sydney RPSD team.

  • Contribute to process improvements and advocate best practices in tools like Jira, Confluence, and RIMSYS.

Required Skills and Qualifications:

  • Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.

  • 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices).

  • Proven experience leading or coordinating global regulatory submissions (e.g., 510(k), CE Marking, TGA ARTG).

  • Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.

  • Excellent communication, project planning, and cross-functional influence skills.

Benefits of this Role:

  • Be part of a dynamic and diverse team driving innovation in healthcare.

  • Develop and apply expertise in regulatory affairs and technical documentation.

  • Partner with cross-functional teams to drive global submission readiness and change assessments.

Qualifications and Experience Required

Requirements:

  • Professional certifications in regulatory affairs or related fields are highly valued.

  • Experience working with ResMed-type devices (CPAP, ventilators, masks, accessories) and familiar with device-specific standards (e.g., ISO 17510, ISO 80601-2-70, IEC 60601, ISO 18562).

  • Hands-on experience with submission platforms and document control tools (e.g., RIMSYS, Jira, Confluence).

Who We Are Looking For

We are looking for someone who thrives in structured environments, applies high analytical rigor, and consistently delivers compliant, high-quality documentation. If you understand that regulatory excellence is built not just on what you deliver—but how you support those around you to do the same—we want to hear from you.

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