Senior Regulatory Affairs Associate

Solventum

Senior Regulatory Affairs Associate ensuring compliance for medical devices in Australia. Collaborating with cross-functional teams and regulatory bodies for product registrations and documentation.

Posted 7/5/2026full-timeNorth Ryde • 🇦🇺 AustraliaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory compliance for medical devices, including strong knowledge of TGA, Medsafe, ISO 13485, and MDR. Capable of developing and maintaining regulatory documentation while effectively collaborating with cross-functional teams and regulatory authorities.

Highest-signal resume keywords

Regulatory Affairs ExperienceClass III Device ApplicationData Analytics/Reporting SkillsISO 13485 KnowledgeCritical Thinking Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceRisk AssessmentRegulatory DocumentationTechnical File DevelopmentQuality Management System RecordsPost Market ActivitiesArtwork/Packaging ReviewData AnalyticsConformity AssessmentRegulatory Submissions

Soft Skills

Excellent Communication SkillsInterpersonal SkillsAttention to DetailCollaboration SkillsAbility to Prioritize

Industry Keywords

Medical Device IndustryTGAMedsafeMDRRegulatory FrameworksHealth DisciplineRegulatory LandscapeCompliance IssuesIndustry TrendsRegulatory Authorities

About the role

Key responsibilities & impact

Ensures regulatory compliance of the Health Care Business products for ANZ
Develops and maintains documentation relevant to assessment of risk to human health and the environment
Prepares and files regulatory document to Australia and New Zealand Healthcare Authorities for registration
Collaborates with cross-functional teams to compile and submit regulatory submissions for medical devices in accordance with local regulations and guidelines
Supports the development and maintenance of regulatory documentation, including technical files, design dossiers, and quality management system records
Interacts with regulatory authorities to address inquiries, provides necessary documentation, and resolves any compliance issues
Stays updated on industry trends, new regulations, and changes in the regulatory landscape, providing valuable insights to the team
Performs post market activities to support product compliance
Reviews Artwork/ Packaging materials supporting compliance and registration of product

Requirements

What you’ll need

A bachelor's degree in a relevant scientific or health discipline
Strong Data Analytics/Reporting skill set
Demonstrated experience in regulatory affairs within the medical device industry
Class III Device Application and Conformity Assessment experience
Solid understanding of regulatory frameworks, such as TGA (Therapeutic Goods Administration) and Medsafe
Strong knowledge of ISO 13485, MDR (Medical Device Regulation), and other applicable standards
Excellent written and verbal communication skills, with the ability to communicate complex regulatory concepts effectively
Strong interpersonal skills, with the ability to collaborate and interact with teams both locally and internationally
Critical Thinking skills that inform regulatory strategy
Meticulous attention to detail and a keen eye for accuracy
Ability to prioritize in a dynamic environment

Benefits

Comp & perks

Professional development opportunities
Flexible work arrangements