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This position is part of Novanta’s Advanced Surgery (AS) business unit group. Novanta offers highly reliable, precise and safe solutions that enhance system performance and improve patient outcomes. Insufflators, pumps and disposable tube sets, along with medical visualization and operating room integration technologies are the preferred solution for minimally invasive surgery applications.
Summary
The Medical Affairs (Clinical Affairs) Manager is held responsible for keeping a product or product group compliant with regulations and guidelines. The employee ensures the proper implementation of procedures that demonstrate the conformity of medical devices with the relevant clinical performance and safety requirements as well as the documentation required by MDR/MEDDEV.
Primary Responsibilities
- Provide and update regulatory documentation, such as Post Market Surveillance (PMS) Plans, PMS Reports and/or Periodic Safety Update Reports (PSUR), Post-Market Clinical Follow-up (PMCF) documentation (Plan and Report), and/or Clinical Evaluations (Plan and Report) for a product or product group (products in development and new and legacy products)
- Documentation must be up to date to be audit-ready anytime
- Focusing on Medical Affairs related processes such as PMS, PMCF, Clinical Evaluation, Risk Management, Change Management and Nonconformance/Corrective and Preventive Action to ensure required input and output documentation
- Conduct scientific literature and/or vigilance searches, evaluations and reviews according to MDR/MEDDEV 2.7.1 rev. 4
- Establish and perform study planning for CE-registrations and PMCF studies (ISO 14155)
- Collaboration with Regulatory Affairs, Product Management, R&D, and/or external service providers to support PMS, PMCF, Clinical Evaluation documentation
- Conduct annual PMCF Surveys in hospital environment, participation in professional conferences to gain clinical experience and innovation
General Tasks
- Strict compliance with the quality, occupational safety and environmental regulations
- Implementation of the instructions of the quality / environmental management representative and the occupational safety specialist
Required Experience, Education, Skills, Training and Competencies
- University degree (Diploma/Master) in life science/natural science or an equivalent qualification; PhD would be a plus
- Professional experience in the medical device industry or similar field of work is required
- Basic understanding of Medical Affairs processes and tasks is required
- Expert knowledge and experience in medical writing (literature as well as vigilance search, evaluation and review; database management) is required
- Proven track record in creation, editing and proof-reading of Clinical Evaluation Plans and Reports (PRISMA & PICO analysis) to assess the safety and performance, in accordance with applicable standards
- Strong attention to detail and maintaining accurate and thorough documentation at all times
- Knowledge of regulatory requirements (MDR, relevant MDCGs and MEDDEV; ISO 13485, ISO 14971, QSR (FDA), ISO 14155) is required
- Knowledge of Clinical indication and application in Minimally Invasive Surgery is a plus
- Expert knowledge and experience in Medical Device / Clinical investigation (ISO 14115) and/or pharmaceutical industries is a plus
- Fluent written and spoken English (at least C1) is required; German language skills is a plus
- Open and competent attitude when working with your stakeholders
- IT affinity and proficiency with the MS Office package
- Familiarity with AI tools is a plus
Travel Requirements
- Travel by public transportation including train and airplane on demand
- Passport for international travel (fairs, congresses, conferences, customer & internal meetings, OR visits)
Physical Requirements
- Mobility to work in a standard office setting and to use standard office equipment, including a computer.
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