Job Title: Active Medical Device Lead Auditor and Technical Expert
Company: Medical Device Notified Body
POSITION OVERVIEW
We are seeking an experienced Active Medical Device Lead Auditor and Technical Expert to join our conformity assessment team. In this role, you will play a critical part in evaluating the safety, performance, and regulatory compliance of active medical devices from manufacturers worldwide.
KEY RESPONSIBILITIES
* Conduct comprehensive reviews of technical documentation for assigned active medical devices, assessing compliance with Regulation (EU) 2017/745 (Medical Device Regulation - MDR)
* Evaluate Quality Management Systems (QMS) against ISO 13485 requirements to ensure conformity and continuous improvement
* Lead and perform audits of medical device manufacturers, including on-site assessments and remote evaluations
* Manage certification activities for an international portfolio of active medical device manufacturers throughout the conformity assessment lifecycle
* Prepare detailed audit reports, non-conformity findings, and technical assessments
* Provide expert technical guidance on regulatory requirements and quality standards
* Collaborate with multidisciplinary teams to support decision-making in certification processes
* Stay current with evolving regulatory frameworks, standards, and industry best practices
REQUIRED QUALIFICATIONS
* Degree or post-graduate degree in scientific disciplines such as Biomedical Engineering, Biotechnology, Biology, Chemistry, Pharmacy, Bioengineering, or equivalent field
* Extensive professional experience in the active medical device industry, with demonstrated knowledge of device design, development, manufacturing, or quality assurance
* Previous experience in regulatory affairs, quality management, or auditing is highly desirable
* Strong understanding of EU MDR (2017/745) and ISO 13485 requirements
* Knowledge of risk management (ISO 14971), usability engineering, and clinical evaluation processes
* Familiarity with active medical device technologies and their specific regulatory requirements
* Excellent command of English (minimum B1 level; higher proficiency preferred)
* Strong written and verbal communication skills for report writing and stakeholder engagement
* Availability for national and international travel
* Strong analytical and problem-solving abilities
* High attention to detail and ability to work independently
* Professional integrity and commitment to impartiality
WHAT WE OFFER
* Opportunity to work with cutting-edge medical technologies
* Professional development and training in regulatory affairs
* International work environment with diverse client portfolio
#J-18808-Ljbffr