Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.
Regulatory Affairs & QMS Manager.
Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:
Regulatory Affairs & Compliance:
- Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
- Interpret and apply global medical device regulations and standards.
- Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
- Maintain regulatory intelligence and proactively communicate changes to the organization.
- Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
- Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
Quality Management System (QMS):
- Serve as the QMS Management Representative as required by ISO 13485.
- Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
- Lead internal audits, management reviews, and risk management activities.
- Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
- Monitor and report on QMS performance metrics and key quality indicators (KPIs).
- Ensure proper document control and change management processes are implemented.
- Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
About the company:
- American startup with senior management team based in US, Europe and Singapore
- Hybrid work arrangement - 2 days in office, 3 days working from home
- Excellent medical insurance coverage
- Good variable bonus structure
- Great working culture
- Excellent office location (Central - just beside MRT)
Interested applicants, kindly send in a copy of your updated resume in WORD document to [Confidential Information] stating your current and expected remuneration together with notice period required to current employer.
You can also contact Vincent Low for a confidential discussion at 6749 4236.
EA Personnel Registration No: R1324700
