MDR Compliance & Documentation Specialist

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

MDR Compliance & Documentation Specialist

The MDR Compliance Consultant plays a vital role in ensuring adherence to the Medical Device Regulation (MDR) by supporting the creation, review, and maintenance of MDR technical documentation. This role provides expert regulatory guidance, helping the organization navigate MDR complexities to achieve market approval and maintain post-market surveillance compliance.

Purpose of Position

The MDR Compliance Consultant plays a vital role in ensuring adherence to the Medical Device Regulation (MDR) by supporting the creation, review, and maintenance of MDR technical documentation. This role provides expert regulatory guidance, helping the organization navigate MDR complexities to achieve market approval and maintain post-market surveillance compliance.

Job Responsibilities

• 1. MDR Technical Documentation Development
  • Support the preparation, review, and maintenance of MDR‑compliant technical documentation, including:
  • Clinical Evaluation Reports (CER)
  • Risk Management Files
  • Usability Testing Documentation
  • Post‑Market Surveillance (PMS) Reports
  • Design and Manufacturing Information
  • Ensure all technical documents align with MDR requirements and harmonized standards.
  • Conduct and document risk assessments in compliance with MDR regulations.
  • Provide expert advice on preparing technical documentation for regulatory submissions.
• 2. MDR Compliance and Regulatory Support
  • Develop regulatory strategies to achieve and maintain MDR compliance.
  • Collaborate with internal and external stakeholders to ensure compliance with MDR requirements.
  • Review and assess technical documentation against MDR and ISO standards.
  • Assist in preparing for Notified Body audits and regulatory inspections.
• 3. Cross‑Functional Collaboration
  • Work closely with Regulatory Affairs, Quality Assurance, Clinical, and R&D teams to maintain accurate and up‑to‑date technical documentation.
  • Support the implementation of internal compliance processes aligned with MDR.
• 4. Post‑Market Surveillance & Vigilance
  • Develop and implement MDR‑compliant post‑market surveillance systems.
  • Ensure systematic collection, analysis, and reporting of post‑market data, including adverse events and complaints.
  • Prepare Post‑Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSURs).
• 5. Training & Awareness
  • Provide training and guidance to internal teams on MDR requirements and best practices.
  • Stay updated on MDR regulatory changes and ensure relevant teams are informed of updates affecting compliance.
• 6. Audit and Inspection Support
  • Assist in internal audits and MDR compliance assessments.
  • Support responses to regulatory audits and inspections by Notified Bodies or regulatory authorities.

Key Accountabilities

• Technical Documentation: Prepare, review, and maintain MDR‑compliant documentation.
• Regulatory Strategy: Provide guidance for MDR compliance and regulatory submissions.
• Data Interpretation & Reporting: Analyze technical data, identify gaps, and provide clear reports.
• Cross‑Functional Collaboration: Partner with teams to ensure MDR compliance throughout the product lifecycle.
• Post‑Market Surveillance: Ensure effective collection and analysis of post‑market data for continuous regulatory adherence.
• Quality Management: Support document management, audits, and quality system compliance under ISO 13485.

Education & Experience

1. Education

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

2. Experience

• Proven experience in Regulatory Affairs, Compliance, or Technical Documentation within MedTech, Pharma, or a related industry.
• Hands‑on experience with MDR (EU 2017/745), including regulatory submissions, technical documentation, and CE marking.
• Strong familiarity with ISO 13485 (Quality Management Systems for Medical Devices).
• Experience with ISO 14971 (Risk Management for Medical Devices) and its application to risk documentation.
• (Preferred) Exposure to pre‑clinical studies or in‑vitro testing documentation, particularly in device development and safety documentation.