Lead Compliance Engineer at ResMed

Elevate health technology as a Lead Compliance Engineer s senior position focuses on Software as a Medical Device solutions while ensuring regulatory compliance for product safety.

In this pivotal role, you will collaborate with software engineering teams to impact product design and meet medical device regulations. Your expertise will be vital in conducting audits, managing documentation, and implementing Risk Management Plans to uphold product safety and security standards.

Key Responsibilities:

• Serve as primary SME for audits of Software as a Medical Device

• Develop and implement comprehensive Risk Management Plans

• Oversee management of critical product specifications

• Conduct technical design reviews ahead of product launches

• Perform detailed post-market assessments on incidents

Requirements:

• Bachelor's or Master's in engineering or relevant field

• 4-5 years of experience in medical device industry

• 3-5 years working with ISO standards

• Strong skills in technical documentation

• In-depth familiarity with industry regulations and standards

Utilize your compliance expertise to enhance product safety and trust as a Senior Compliance Engineer with Res Med.
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