Build a career powered by innovations that matter! 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 Minimally Invasive Surgery (MIS) 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
This position serves as a point of contact for medical/clinical issues and is responsible for providing expertise for post-market surveillance activities as well as creating and updating PMS relevant documentation.

Primary Responsibilities

• Regular update of PMS SOPs based on MDR requirements, guidance documents (MDCGs) and/or (international) regulatory requirements (MDSAP, ROW)
• Provision and timely update of PMS documents
• Overview of all PMS documents and the respective revision status across Novanta business units
• Collection, evaluation and updating of PMS relevant data received from other departments, e.g. Complaint and Product Management
• Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4
• Provide searches in relevant vigilance databases
• Support for risk analysis and assessment of benefit-risk-ratio
• Collection, evaluation and preparation of customer data for PMS
• Preparation of data for forwarding to customers for their own PMS

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 and PhD in life science/natural science or an equivalent qualification
• Professional experience in the medical device environment or another regulatory field of work
• Intensive knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs
• Hands-on experience in PMS documentation activities, clinical evaluation and PMCF
• Hands-on experience in literature search and review required as well as knowledge of regulatory medical writing
• Intensive knowledge of database management (e.g. PubMed, EMBASE, MAUDE, BfArM, EUDAMED)
• Open and competent attitude when working with your stakeholders
• Fluent written and spoken English
• Ability to autonomously coordinate complex workflows
• Structured, systematic and proactive working approach

Travel Requirements

• Attendance on conferences, conferences and trade shows
• Willingness to travel to all Novanta locations and business contacts

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Prelouc

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

Primary Responsibilities

• Regular update of PMS SOPs based on MDR requirements, guidance documents (MDCGs) and/or (international) regulatory requirements (MDSAP, ROW)
• Provision and timely update of PMS documents
• Overview of all PMS documents and the respective revision status across Novanta business units
• Collection, evaluation and updating of PMS relevant data received from other departments, e.g. Complaint and Product Management
• Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4
• Provide searches in relevant vigilance databases
• Support for risk analysis and assessment of benefit-risk-ratio
• Collection, evaluation and preparation of customer data for PMS
• Preparation of data for forwarding to customers for their own PM

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