Product Manager / Medical Affairs (m/f/d)

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Product Manager – Medical Affairs (m/f/d)

Apply locations Berlin, Germany time type Full time posted on Posted Yesterday job requisition id R007611

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.

The Product Manager with a focus on Medical Affairs (Clinical Affairs) is 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 (Plan and Report), Post-market Clinical Follow-up (plan and report) for a product or product group.
• 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 with 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, participate 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 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 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.

Travel Requirements

• Travel by public transportation including train and airplane on demand.
• Passport for international travel (fairs, congresses, conferences, customer & internal meetings, OR visits).

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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.

About Us

Solving complex challenges, delivering innovations that matter!
Novanta is a trusted technology partner to medical and advanced industrial OEMs (original equipment manufacturers), with deep proprietary expertise in photonics, vision and precision motion technologies. We engineer mission-critical core components and subsystems that deliver extreme precision and performance, enabling our customers to improve productivity, achieve breakthrough performance and enhance people’s lives. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation and customer success. Novanta’s common shares are quoted on NASDAQ under the ticker symbol “NOVT”.

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