Regulatory Affairs Manager

RA Manager will be responsible for establishing, maintaining, and continuously improving company's Quality Management System in compliance with ISO 13485, CE-MDR, US FDA, and international regulatory requirements. This role will ensure product portfolio meets the highest quality, safety, and regulatory standards for global commercialization.

Qualifications & Experience

- Bachelor's or master's degree in biomedical engineering, Regulatory Affairs, Quality Management, or related field.

Experience of regulatory affairs experience in medical devices (Preferred).

-Strong understanding of regulatory frameworks in [APAC/Global/Local Market].

-Proven track record in handling submissions, renewals, and product lifecycle management.

-Excellent communication skills and ability to work with regulatory agencies.

-Strong attention to detail, analytical thinking, and problem-solving ability.

- Proven track record of ISO 13485 certification and CE-MDR submissions. FDA experience highly desirable.