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 Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine, WOM develops devices and accessories so that doctors can operate with small cuts. We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate.
Summary
As a Regulatory Affairs Specialist, you will ensure product compliance with regulations and guidelines. You will evaluate regulations, liaise with authorities and guide internal teams in regulatory matters.
Primary Responsibilities
Medical device approval:
• Assistance with the compilation of registration-relevant documents on requests of customers in third countries incl. free sales certificates, legalizations, other declarations and certificates
• Assistance with the compilation of documents for documentation tests by the Notified Body of W.O.M. within the scope of approval procedures according to EU Medical Devices Directive
• Support with the control/acceptance of technical documentation within the framework of the conformity assessment procedure, assessment of compliance with the Essential Requirements, preparation and release of declarations of conformity.
Design control and change management:
• Participation in the implementation of the risk management process, clinical evaluation and usability file as part of the design control process Elaboration and updating of design guidance procedures and subordinate policies and procedures
• Review/approval of regulatory documents in the context of design governance, in particular:
Risk Analysis/Risk Management, Clinical Evaluation, Design Validation/Design Verification Plans and Protocols, Software Documentation, Instructions for Use and Product Labels
• Processing of change processes and checking for relevance to approval
• Assistance with general inquiries regarding RA
Customers and externals:
• Interface to the RA departments of the customers, to the Notified Body and authorities
• Accompaniment of audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMB
General tasks
• Active participation in measures to maintain the QMS (e.g. process adaptation)
• Active participation in the innovation process
• Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions from quality/environmental management representatives and the occupational safety specialist
Responsible/authorized to make decisions
• Provide solutions to problems that require a certain amount of evaluation and interpretation of information
• Act as a consultant to less experienced personnel and train accordingly.
Required Experience, Education, Skills, Training and Competencies
• 1-2 years of relevant professional experience
• Ability to conduct extensive research, in-depth knowledge and creativity
• Anticipate, identify, define and solve the most complex problems. Ability to analyze proposed solutions to solve problems with far-reaching and long-term implications
• General knowledge of the manufacturing process is required
• Quality-conscious, trustworthy and reliable
• Team player
• Communicative skills
• Structured and systematic way of working
Additional qualifications:
• Manager Regulatory Affairs - Medical Devices
• Independent use of English (CEFR-B2)*
*) Common European Framework of Reference for Languages (CEFR)
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Travel Requirements
• Willingness to travel to different NOVT locations and business partners - Up to 10% traveling time
Physical Requirements
• None
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.