Microbiology CE Technical Specialist

Job Title: Technical Specialist - Microbiology (QMS & PMD)
Location: Japan (Home-Based)


Purpose of Position: Provide technical expertise in sterilization and microbiology to review medical device technical documentation and quality systems. Conduct audits to ensure compliance with regulatory requirements. Deliver microbiological technical documentation reviews and audits for various certification schemes. Offer leadership and mentoring in microbiology and medical device QMS assessment. Support the commercial team with technical expertise.

Key Responsibilities:

• Review sterility assurance aspects of medical device technical documentation and quality systems.
• Deliver medical device CE/UKCA Marking technical reviews and ISO 13485/MDSAP QMS assessments.
• Conduct audits of clients' management systems to ensure regulatory compliance.
• Manage travel arrangements and bookings.
• Review critical data, identify external expertise needs, and make recommendations for certificate issuance.
• Analyze risks and benefits to make informed decisions regarding certificate issuance or withdrawal.
• Advise and support product technical specialists and scheme managers.

Key Dimensions:

• Work as a member of the Microbiology Team, reporting to the Technical Team Manager.
• Influence all levels of the organization and client/regulatory management.
• Position is home-based with significant travel.

Knowledge, Skills, and Abilities:

• Degree-level or equivalent Microbiologist with at least 4 years' experience in medical device or related regulatory field.
• Hands-on experience in microbiological testing and sterile product manufacturing.
• Thorough knowledge of Medical Device regulation.
• Understanding of product certification and service delivery.
• Knowledge of business processes and quality management standards.
• Analytical thinking, efficiency, and results-orientation.
• Team player with strong relationship-building skills.
• Broad technical understanding of clients, medical device industry, and sterile products.
• Ability to travel extensively.
• Fluency in Japanese is essential.