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.

• Provide and update PM-related regulatory documentation, such as Clinical Evaluations (Plan and Report), Post-market Clinical Follow-up (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

• Coordination of PM-related Regulatory Processes such as Clinical Evaluation, Post Market Clinical Follow-up/Post Market Surveillance, Usability, Risk Management, Health risk assessment and Hazardous Situations to ensure required input documentation is ready before audit deadline

• Conduct scientific literature 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)

• Coordinate cross-functional teams and collaborate Regulatory Affairs, R&D, Medical Affairs as well as external service providers to support clinical evaluation documentation, PMCF and PMS

• Conduct annual market analysis for competitive products to identify equivalence to existing devices

• Conduct annual PMCF Surveys in hospital environment, participation in professional conferences to gain clinical experience and innovation

• 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

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

• A PhD is required for this position

• Professional experience in the medical device environment or similar field of work

• Basic understanding of product management responsibilities and tasks is required as this position functions as an interface to PM and RA

• 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

• Knowledge of Clinical indication and application in Minimally Invasive Surgery is a plus

• Experience in product management is a plus

• Knowledge in regulatory requirements (MDR, relevant MDCGs and MEDDEV; ISO 13485, ISO 14971, QSR (FDA), ISO 14155)

• Expert knowledge and experience in Medical Device / Clinical investigation (ISO 14115) and/or pharmaceutical industries is a plus

• Experience in medical writing, in literature search and review is required

• Knowledge of database management

• Open and competent attitude when working with your stakeholders

• IT affinity and proficiency with the MS Office package

• Fluent written and spoken English is a must, German would be beneficial
• Requires the ability to synthesize multiple inputs. Decision making involves in-depth knowledge, creativity, and managerial courage.

• Requires that the most complex organizational and operational problems are anticipated, identified, defined, and resolved to support changing business conditions. Solutions must support the values, strategic direction, and long-term success of the company.

• Travel by public transportation including train and airplane on demand

• Passport for international travel (fairs, congresses, conferences, customer & internal meetings, OR visits)

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.