Regulatory Affairs Manager

2 weeks ago

Melbourne, Australia KE Select Full time

Leadership Position in the Regulatory Affairs Department
- IVD Medical Devices and EMCD Regulation
- International Manufacturer of Clinical Diagnostic Instruments

**Regulatory Affairs Manager (VIC) | IVD Medical Devices**

***

**About the Company**
This is your opportunity to be a part of a global manufacturer of clinical diagnostics laboratory instruments. The company specialises providing automated workflow solutions and equipment often used for clinical diagnostics.

**About the Role**
This position is based in Melbourne and allows for a hybrid work arrangement. Managing a team of Regulatory Affairs Specialists and working closely with quality assurance team, the Regulatory Affairs Manager is responsible for leading all aspects of the company’s regulatory obligations.

**Responsibilities**:

- Product registrations and regulatory intelligence
- Post-market surveillance and vigilance activities
- Regulatory compliance assessments
- Providing regulatory input/strategy for new product development and device changes

**About the Person**
This position is ideal for experienced regulatory affairs professionals with expertise in IVD or medical devices

Essential:

- Graduate qualifications in a science, medical or technical fields
- 5+ years’ experience in IVD/medical device regulatory affairs
- Knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820 and ISO 13485.
- Prior experience in team leadership or management roles

KE Select are a leading provider of Scientific, Medical and Technical recruitment services. For a confidential discussion, please contact Sylvester at

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