MDR Consultant

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

MDR Compliance and Documentation Consultant supporting the creation, review, and maintenance of MDR technical documentation for medical devices, ensuring compliance with regulatory requirements and applicable harmonized standards.

Key responsibilities

Support the creation, review, and maintenance of MDR technical documentation including clinical evaluation reports, risk management files, usability testing documentation, post-market surveillance reports, and design and manufacturing information

Ensure all technical documents align with MDR requirements and applicable harmonized standards

Ensure appropriate risk assessments are conducted and documented as per MDR requirements

Provide expert advice on the preparation of technical documentation for regulatory submissions

Provide consultancy on regulatory strategies for achieving MDR compliance

Collaborate with internal and external stakeholders to ensure all product-related documents meet MDR requirements

Review and assess technical documentation for compliance with the latest updates in MDR and ISO standards

Assist in preparing for Notified Body audits and inspections, ensuring technical documentation is complete and compliant

Work closely with regulatory affairs, quality assurance, clinical, and R&D teams to ensure all aspects of MDR technical documentation are accurate and up-to-date

Support the development and implementation of post-market surveillance systems that comply with MDR

About you

Bachelor's or Master degree in Biomedical sciences, Regulatory Affairs or related fields

Previous experience in a similar regulatory affairs, compliance, or technical documentation role within MedTech, Pharma, or a related industry

Hands-on experience in ensuring medical device products meet regulatory requirements, preparing technical documentation, risk management files, and CE marking for the European market

Direct experience in creating, reviewing, and managing technical documentation including design dossiers, clinical evaluation reports, and post-market surveillance plans in compliance with MDR

Strong familiarity with ISO 13485 and how it aligns with regulatory requirements for medical devices

Experience working with ISO 14971 and understanding its application to the creation of risk management documentation for medical devices

Good communications skills with professional level English required

Teamworking skills, integrity, drive and organizational skills

Able to handle documents attentively

Bactiguard (South East Asia) Sdn. Bhd. is a Swedish medical device company with a mission to save lives. To achieve this mission, we develop and supply infection prevention solutions which reduce the risk of healthcare associated infections and the use of antibiotics. In this way, we save significant costs for healthcare and the society at large.

Join us and be part of a company that innovates and provides patented technological solutions across the healthcare industry. We are a growing company, established in providing medical device solutions with a Mission to Save Lives, from hospitals, pharmacies, clinics, and patients.