Solventum15 jobs

Senior Regulatory Affairs Associate

Mid levelSeniorFull-timeHybridSydney NSW, AustraliaPosted 1 month agoVerified 1 month 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.

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

View

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.

View

Interpersonal skills
Strong interpersonal skills for effective collaboration with teams.

View

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