• Lead global QMS and regulatory compliance for breakthrough innovation
• Drive impact across worldwide

About Our Client

Our client is a pioneering healthcare innovator dedicated to transforming the future of medical technology. Backed by over a decade of research and significant global investment, they have introduced a first-of-its-kind device that is redefining standards in patient care. With recent regulatory approvals and a strong commercialisation roadmap, this organisation offers an exciting opportunity to be part of a mission-driven team delivering breakthrough solutions to healthcare providers worldwide.

Job Description

• Act as QMS Management Representative under ISO 13485
• Maintain and continuously improve QMS compliance with ISO 13485, EU MDR and FDA
• Lead internal audits, management reviews and risk management activities
• Drive CAPA systems and support root cause analysis
• Monitor and report QMS performance metrics and KPIs
• Ensure document control and change management processes
• Develop and deliver QMS training programs, including onboarding and refreshers
• Serve as Person Responsible for Regulatory Compliance (PRRC) under EU MDR
• Interpret and apply global medical device regulations and standards
• Prepare and submit regulatory dossiers and product registrations globally
• Maintain regulatory intelligence and communicate changes proactively
• Review and approve marketing and promotional materials for compliance
• Oversee complaint evaluation and vigilance reporting for adverse events
• Lead audit and inspection readiness activities and act as primary contact during audits
• Coordinate timely resolution of audit findings and corrective actions
• Participate in supplier audits as needed

The Successful Applicant

• Bachelor's degree in science, engineering, or regulatory discipline or a related field
• Experience in quality and regulatory roles within the medical device industry
• Expertise in ISO 13485, EU MDR, and FDA
• Prior experience as Management Representative and/or PRRC highly desirable
• Strong analytical, leadership and communication skills
• Excellent communication and stakeholder engagement skills

What's on Offer

• Opportunity to lead compliance for a globally impactful healthcare innovation
• Dynamic, mission-driven environment with international exposure

Contact

Vanessa Chan (Lic No: R2197577/ EA no: 18S9099)

Quote job ref

JN-112025-6883914

Phone number

+65 6643 9742