ResMed
At ResMed, we're dedicated to transforming lives through cutting-edge health solutions. We're currently looking for a Post-Market Regulatory Affairs Consultant to enhance our compliance efforts during a pivotal time for our team.
This is an exceptional opportunity for a seasoned regulatory professional to play a critical role in ResMed's mission by ensuring that our marketed medical devices remain compliant across various global markets.
About the Role
In this position, you will collaborate with the Regulatory Affairs team on a range of post-market activities to uphold compliance for ResMed's medical devices. You'll engage with stakeholders in Quality, Product Development, and Global Product Management, providing valuable regulatory insights, conducting assessments, and supporting product lifecycle initiatives. Key Responsibilities Represent Regulatory Affairs in selected cross-functional post-market teams Conduct and document post-market regulatory assessments (e.g., FDA, TGA, EU Notified Bodies) Support medical device reporting (MDR) and post-market surveillance activities Track and analyze updates to global regulatory standards (FDA, EU MDR, ISO, IEC) to ensure compliance Contribute to special projects aimed at ensuring business continuity and regulatory compliance Qualifications
A degree in Engineering, Science, or a related field Minimum of 6 years' experience in medical device regulatory affairs Proven hands-on experience with post-market regulatory tasks Exceptional documentation, organizational, and communication skills Ability to work independently in a flexible, part-time consultancy arrangement Preferred Qualifications: Familiarity with EU MDR post-market surveillance and ISO 13485 standards Experience with multiple global markets (e.g., US FDA, TGA, EU) Capacity to adapt quickly and prioritize effectively in a dynamic environment Engagement Details:
Part-time (3 days per week), 6-month contract, remote work with an immediate start preferred. Joining us means more than just accepting a job; it’s about embarking on a rewarding career that’s both fulfilling and inspiring. Our culture fosters excellence, motivating you not only to meet your objectives but also to set new ones. We prioritize an inclusive and diverse environment where individual expression thrives, leading to innovative ideas. If this resonates with you, we invite you to apply now!
In this position, you will collaborate with the Regulatory Affairs team on a range of post-market activities to uphold compliance for ResMed's medical devices. You'll engage with stakeholders in Quality, Product Development, and Global Product Management, providing valuable regulatory insights, conducting assessments, and supporting product lifecycle initiatives. Key Responsibilities Represent Regulatory Affairs in selected cross-functional post-market teams Conduct and document post-market regulatory assessments (e.g., FDA, TGA, EU Notified Bodies) Support medical device reporting (MDR) and post-market surveillance activities Track and analyze updates to global regulatory standards (FDA, EU MDR, ISO, IEC) to ensure compliance Contribute to special projects aimed at ensuring business continuity and regulatory compliance Qualifications
A degree in Engineering, Science, or a related field Minimum of 6 years' experience in medical device regulatory affairs Proven hands-on experience with post-market regulatory tasks Exceptional documentation, organizational, and communication skills Ability to work independently in a flexible, part-time consultancy arrangement Preferred Qualifications: Familiarity with EU MDR post-market surveillance and ISO 13485 standards Experience with multiple global markets (e.g., US FDA, TGA, EU) Capacity to adapt quickly and prioritize effectively in a dynamic environment Engagement Details:
Part-time (3 days per week), 6-month contract, remote work with an immediate start preferred. Joining us means more than just accepting a job; it’s about embarking on a rewarding career that’s both fulfilling and inspiring. Our culture fosters excellence, motivating you not only to meet your objectives but also to set new ones. We prioritize an inclusive and diverse environment where individual expression thrives, leading to innovative ideas. If this resonates with you, we invite you to apply now!