- 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
