MDR Regulatory Compliance Consultant for Medical Devices

BACTIGUARD ( SOUTH EAST ASIA) SDN. BHD.; Simpang Ampat; On-site; MYR 120,000 - 180,000; Full time

Job summary

BACTIGUARD (South East Asia) Sdn. Bhd. seeks an MDR Compliance and Documentation Consultant to support MDR technical documentation creation, review, and maintenance for medical devices, ensuring alignment with MDR requirements and harmonized standards.

You will collaborate with regulatory affairs, quality assurance, clinical and R&D teams to keep documents current, perform risk management alignment, and assist in audit preparation and regulatory submissions.

Qualifications

• Bachelor’s or Master degree in Biomedical sciences, Regulatory Affairs or related fields.
• Experience in regulatory affairs, compliance, or technical documentation in MedTech, Pharma, or related industry.
• Hands-on in MDR/CE marking prep and technical documentation creation.
• Direct experience with design dossiers, clinical eval reports, and post-market plans.
• Familiarity with ISO 13485 and MDR alignment.

Responsibilities

• Support the creation, review, and maintenance of MDR technical documentation including CVRs and risk files.
• Ensure all documents align with MDR requirements and harmonized standards.
• Conduct and document risk assessments per MDR requirements.
• Provide expert advice on regulatory submissions and MDR strategy.
• Collaborate with stakeholders to ensure all product documents meet MDR
• Review for MDR/ISO updates and prepare for Notified Body audits
• Work with regulatory affairs, QA, clinical, and R&D to keep docs accurate

Skills

Regulatory compliance

Technical documentation

ISO 13485

ISO 14971

English communication

Education

Bachelor’s or Master degree in Biomedical sciences or Regulatory Affairs

Job description

BACTIGUARD (South East Asia) Sdn. Bhd. seeks an MDR Compliance and Documentation Consultant to support MDR technical documentation creation, review, and maintenance for medical devices, ensuring alignment with MDR requirements and harmonized standards.

You will collaborate with regulatory affairs, quality assurance, clinical and R&D teams to keep documents current, perform risk management alignment, and assist in audit preparation and regulatory submissions.