Solventum12 jobs

Senior Regulatory Affairs Associate

Mid levelSeniorFull-timeHybridSydney NSW, AustraliaPosted 1 week agoVerified 1 week ago
Pending fitX of Y criteria met

About the job

The Senior Regulatory Affairs Associate job at Solventum is all about ensuring regulatory compliance for healthcare products in Australia and New Zealand. This position plays a crucial role in developing documentation, preparing regulatory submissions, and collaborating with cross-functional teams to navigate the regulatory landscape. At Solventum, teamwork and innovation are at the forefront, creating an environment where every team member contributes to improving lives through healthcare solutions.

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You'll be responsible for

✅

Ensuring regulatory compliance

Ensures regulatory compliance of the Health Care Business products for Australia and New Zealand.
📄

Preparing regulatory submissions

Prepares and files regulatory documents to Australia and New Zealand Healthcare Authorities for registration.
🤝

Collaborating with teams

Collaborates with cross-functional teams to compile and submit regulatory submissions for medical devices in accordance with local regulations and guidelines.

Key criteria

📄

Regulatory affairs experience

Demonstrated experience in regulatory affairs for medical devices.

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📊

Data analytics skills

Strong data analytics and reporting skills for informed decision-making.

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🔍

Knowledge of ISO standards

Solid understanding of ISO 13485 and MDR regulations.

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A meaningful career starts with a match

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5 criteria for this job
Regulatory affairs experience
Demonstrated experience in regulatory affairs for medical devices.

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Data analytics skills
Strong data analytics and reporting skills for informed decision-making.

View

Knowledge of ISO standards
Solid understanding of ISO 13485 and MDR regulations.

View

Technical documentation expertise
Experience developing technical files and quality management records.

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Interpersonal skills
Strong interpersonal skills for effective collaboration with teams.

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