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.
Summary
The Product Manager (PM) with a focus on Medical Affairs (Clinical Affairs) is held responsible for keeping a product or product group compliant with regulations and guidelines. The employee ensures the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements together with MDR/MEDDEV required documentation.
Primary Responsibilities
- Provide and update PM-related regulatory documentation, such as Clinical Evaluations (CEv; Plan and Report), Post-market Clinical Follow-up (PMCF; Plan and Report) for a product or product group (products under development and legacy products)
- Documentation must be up to date to be audit-ready anytime
- Coordination of PM-related Regulatory Processes such as CEv, PMCF/Post Market Surveillance (PMS), 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
- 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
- Establish and perform study planning for CE-registrations and PMCF studies (ISO 14155)
- Coordinate cross-functional teams and collaborate Regulatory Affairs (RA), Research & Development (R&D), Medical Affairs as well as external service providers to support clinical evaluation documentation, PMCF/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
- A university degree in life science/natural science or an equivalent qualification is required (PhD would be beneficial)
- Professional experience in the medical device environment or similar field of work
- Proven track record in creation, editing and proof-reading of CEv (PRISMA & PICO analysis) to assess the safety and performance, in accordance with applicable standards
- Expert knowledge and experience in medical writing, in literature search and review is required
- Knowledge of clinical indications and applications in Minimally Invasive Surgery is a plus
- Knowledge in regulatory requirements (MDR, relevant MDCGs and MEDDEV; ISO 13485, ISO 14971, QSR (FDA), ISO 14155)
- Experience in product management is a plus
- Understanding of product management responsibilities and tasks is required as this position functions as an interface to PM and RA
- 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
- 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 Requirements
- Travel (20%) 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.
#LI-UK1
#Berlin
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.
