Global Regulatory Affairs Lead – MedTech & SaMD (Hybrid)

C16 Cochlear Malaysia SDN BHD. (Malaysia); Kuala Lumpur; Hybride; MYR 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

Cochlear Malaysia SDN BHD. is seeking a Regulatory Affairs Specialist to partner with Product Development and R&D in Kuala Lumpur, guiding regulatory strategy for medical devices and software from concept through market release.

You will prepare submissions to FDA, EU Notified Bodies, and international authorities, ensure compliance across global markets, and work closely with cross‑functional teams to manage lifecycle activities and regulatory changes.

Qualifications

• Bachelor's degree in Engineering, Science, Healthcare, Biomedical, Legal or related discipline (or advanced degree).
• 3–8 years’ experience in regulatory affairs and submissions for Class II/III devices or SaMD.
• Excellent written and verbal communication skills.
• Experience preparing technical documentation, reports and regulatory submissions.
• Proven ability to collaborate and influence within cross-functional and global teams.
• Familiarity with global regulatory requirements and cyber security considerations.

Responsabilités

• Provide regulatory and standards guidance throughout product development and lifecycle.
• Define regulatory pathways and documentation requirements for new products and software releases.
• Prepare and coordinate regulatory submissions to agencies including FDA, EU Notified Bodies and international authorities.
• Develop and maintain regulatory dossiers and ensure timely post-approval activities.
• Collaborate with R&D, Quality and regional regulatory teams to align strategy and execution.

Connaissances

Regulatory affairs

Regulatory submissions

Cross-functional collaboration

Communication skills

Regulatory standards

Formation

Bachelor's degree or advanced degree in related discipline

Advanced degree in Engineering/Science/Healthcare/Legal

Outils

IEC 62304

ISO 13485

ISO 14971

Description du poste

Cochlear Malaysia SDN BHD. is seeking a Regulatory Affairs Specialist to partner with Product Development and R&D in Kuala Lumpur, guiding regulatory strategy for medical devices and software from concept through market release.

You will prepare submissions to FDA, EU Notified Bodies, and international authorities, ensure compliance across global markets, and work closely with cross‑functional teams to manage lifecycle activities and regulatory changes.