Senior Regulatory Affairs Quality Officer

We are seeking a Senior Regulatory Affairs Quality Officer to join our organization. The Senior Regulatory Affairs Quality Officer will ensure compliance with applicable regulatory requirements and maintain a robust quality management system.

About the Role:
You will lead activities to maintain and strengthen the quality management system and regulatory compliance program, monitor regulatory requirements, support regulatory submissions as needed, and contribute to audit readiness and inspection support. This is a conceptual overview of responsibilities.

Responsibilities:
- Develop, implement, and maintain the Quality Management System in accordance with ISO 13485 and applicable regulations.
- Monitor regulatory requirements across jurisdictions and ensure ongoing compliance.
- Plan, conduct, and support regulatory compliance audits; drive corrective actions and preventive actions.
- Prepare, review, and maintain regulatory documentation and records to support compliance efforts.
- Collaborate with cross-functional teams to ensure product lifecycle compliance, risk management, and continuous improvement.
- Provide interpretation of regulatory requirements to guide business decisions.

Required Skills:
- ISO 13485
- Quality Management
- Regulatory Compliance
- Regulatory Compliance Auditing

What We Offer:
- A collaborative work environment that supports professional growth.
- Opportunities for ongoing training and development.
- Flexible working arrangements and a balanced workload.
- A platform to contribute to meaningful quality and regulatory work.

How to Apply:
- Interested candidates are invited to submit their resume and a cover letter via the application platform.