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About the Role

This position serves as a point of contact for medical/clinical issues and is responsible for vigilance as well as Post-Market surveillance and Post-Market Clinical Follow-Up activities, focusing on the evaluation of vigilance data, reporting adverse events and performing recalls/FSCAs and/or corrective actions.

Responsibilities

• Evaluation of adverse events based on the event description and medical device investigation results
• Provision of a decision on reporting obligations based on international regulatory requirements
• Reporting of adverse events in line with country-specific requirements
• Search and evaluation of vigilance data for medical devices using country-specific databases
• Support with risk analysis and assessment of benefit-risk-ratio
• Provision of a significant input in Health-Risk Assessments
• Provision of a decision on recall/FSCA obligations based on international regulatory requirements
• Creation of recall/FSCA related documentation
• Point of contact for inquiries from authorities and vigilance related customer interactions
• Regular update of Vigilance related SOPs based on MDR requirements, guidance documents (MDCGs) and/or (international) regulatory requirements (MDSAP, ROW)
• Provision and timely update of PMS and/or PMCF documents
• Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4
• 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

Requirements

• Professional experience in the medical device environment or another regulatory field of work required
• Risk assessment and experience in reporting adverse events in line with country-specific requirements required
• Knowledge of international regulatory requirements for vigilance activities required
• Knowledge of vigilance database management and the evaluation of vigilance data, focusing on the benefit-risk ratio, required
• Open and competent attitude when working with your stakeholders
• Fluent written and spoken English, German would be a big plus
• Ability to coordinate complex workflows
• Structured and systematic working approach
• High-quality documentation skills

Skills

• Experience in literature search and review is beneficial
• Knowledge of regulatory medical writing
• General QMS knowledge

Location

• The Americas
• Europe
• Asia-Pacific

Work Type

• Hybrid

Education Level

• University degree in life science/natural science or an equivalent qualification

About the Company

• At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible.
• We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing.
• Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific.
• Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment.
• Come explore Novanta.
• This position is part of Novanta’s Advanced Surgery 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.

Equal Opportunity

• Novanta is proud to be an equal employment opportunity and affirmative action workplace.
• We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.
• Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.