Regulatory & Business Development Lead, Medical Devices

Cureva Technologies Sdn. Bhd.; Penang; Sur place; MYR 33 000 - 45 000; Plein temps

Avantages offerts par ce poste

Training sponsorship

Leave entitlements

Employer contributions

Résumé du poste

Cureva Technologies Sdn. Bhd. is building regulatory and quality-management for planned medical-device activities in Malaysia. The role supports licensing, documentation, and supplier coordination while learning under professional advisers and the Director.

Ideal candidates have a diploma or degree, strong English, and good organizational skills; Mandarin is a plus. Immediate training and a formal Person Responsible appointment are included in the role.

Qualifications

• Diploma or bachelor’s degree in a relevant field or equivalent.
• Experience in medical devices is advantageous, but not mandatory.
• Ability to coordinate regulatory documentation and governance.

Responsabilités

• Coordinate professional training and licensing applications with advisers.
• Implement GDPMD quality-system with external advisers.
• Prepare regulatory and product documentation for submissions.
• Coordinate supplier and partner documentation and authorisation materials.
• Develop procedures for traceability, distribution controls, and safety reporting.
• Assist with market research, manufacturer communications, and business planning in Malaysia and overseas.

Connaissances

Regulatory affairs

Business development

English communication

Documentation

Attention to detail

Training mindset

Malaysia work eligibility

Formation

Diploma / Bachelor's degree or equivalent

Description du poste

Cureva Technologies Sdn. Bhd. is building regulatory and quality-management for planned medical-device activities in Malaysia. The role supports licensing, documentation, and supplier coordination while learning under professional advisers and the Director.

Ideal candidates have a diploma or degree, strong English, and good organizational skills; Mandarin is a plus. Immediate training and a formal Person Responsible appointment are included in the role.