MDR Regulatory & Technical Documentation Lead

Bactiguard; Seberang Perai; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading medical technology company in Penang, Malaysia is seeking an MDR Compliance & Documentation Specialist to ensure adherence to the Medical Device Regulation (MDR). This role focuses on preparing and maintaining MDR-compliant documentation, developing regulatory strategies, and supporting internal audits. Ideal candidates should have a relevant degree and experience in Regulatory Affairs within the MedTech or Pharma sectors. This position plays a critical role in achieving market approval and maintaining post-market compliance.

Qualifications

• Proven experience in Regulatory Affairs, Compliance, or Technical Documentation within MedTech or Pharma.
• Hands-on experience with MDR (EU 2017/745) including regulatory submissions and CE marking.
• Experience with ISO 13485 and ISO 14971 relating to medical devices.

Responsibilities

• Prepare and review MDR-compliant technical documentation.
• Develop regulatory strategies to achieve and maintain MDR compliance.
• Conduct risk assessments and provide expert regulatory guidance.

Skills

Regulatory Affairs

Compliance

Technical Documentation

Risk Management

Data Analysis

Education

Bachelor’s or Master’s degree in Biomedical Science, Regulatory Affairs or related field

Tools

ISO 13485

ISO 14971

Job description

A leading medical technology company in Penang, Malaysia is seeking an MDR Compliance & Documentation Specialist to ensure adherence to the Medical Device Regulation (MDR). This role focuses on preparing and maintaining MDR-compliant documentation, developing regulatory strategies, and supporting internal audits. Ideal candidates should have a relevant degree and experience in Regulatory Affairs within the MedTech or Pharma sectors. This position plays a critical role in achieving market approval and maintaining post-market compliance.