Posted:
6/18/2025, 1:55:11 PM
Location(s):
New South Wales, Australia ⋅ Sydney, New South Wales, Australia
Experience Level(s):
Mid Level ⋅ Senior
Field(s):
Business & Strategy
We are looking for a Business Process Manager – Regulatory Affairs to lead a dedicated team focused on optimizing regulatory workflows and ensuring global compliance across our operations. This is a critical leadership role where you'll work cross-functionally to drive business efficiency, support transformation, and elevate the performance of the Regulatory Affairs (RA) function.
Process Excellence & Optimization
Lead process mapping and analysis using BPMN 2.0 standards to document, standardize, and improve RA workflows.
Identify bottlenecks and deliver continuous improvement initiatives using proven methodologies (Lean, Kaizen, Six Sigma).
Develop, maintain, and scale Standard Operating Procedures (SOPs) and supporting documentation.
Build and deploy training materials to ensure process adoption and knowledge transfer.
Change Management
Design and implement change management strategies that support the successful rollout of updated or new regulatory processes.
Monitor adoption, gather feedback, and adapt plans as needed to ensure sustained success.
Cross-Functional Collaboration
Act as the bridge between RA and key partners in Quality, Supply Chain, and Product Development to align on requirements, address pain points, and drive end-to-end process efficiency.
Ensure strong communication and transparency with all stakeholders to foster trust and alignment.
Team Leadership
Manage and mentor a high-performing team focused on regulatory process improvement.
Champion a culture of business excellence through coaching, upskilling, and goal-setting.
Serve as a strategic thought partner to RA leadership on business transformation initiatives.
Education: Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related discipline (Advanced degree preferred).
Minimum 5 years of experience in Regulatory Affairs, Quality, Operations, or Process Excellence in a regulated industry.
Proficiency in business process modeling (e.g. BPMN 2.0).
Hands-on experience with continuous improvement tools such as Lean, Six Sigma, or Kaizen.
Strong communication, stakeholder management, and influencing skills.
Ability to work across complex regulatory environments and cross-functional teams.
Proven success in people management, coaching, and developing high-potential talent.
Exposure to Regulatory Affairs in the medical device or pharmaceutical industry.
Professional certifications such as Lean Six Sigma, CBAP, or BPM methodologies.
This is more than a process role — it's an opportunity to shape how regulatory excellence is delivered globally. You’ll influence strategy, lead innovation, and empower teams to work smarter and more effectively. If you’re a collaborative leader with a knack for making complex processes work seamlessly, we’d love to hear from you.
#LI-APAC
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
Website: https://www.resmed.com/
Headquarter Location: San Diego, California, United States
Employee Count: 10001+
Year Founded: 1989
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Health Care ⋅ Medical ⋅ Medical Device