Product Regulatory Affairs Specialist Please apply in English only ABOUT THE ROLE We are looking for a Product Regulatory Affairs Specialist to join our Regulatory Affairs team and play a key role in supporting regulatory activities throughout the lifecycle of innovative medical devices that are transforming cancer care. In this role, you will help ensure that our products meet global regulatory requirements while supporting product development, market access, and ongoing compliance activities. You will work closely with cross-functional teams across R&D, Quality, Clinical, and Marketing, providing regulatory expertise that helps bring innovative technologies to patients worldwide. This is an excellent opportunity for a regulatory professional who enjoys working in a dynamic, fast-paced environment, balancing strategic thinking with hands-on execution. Success in this role means becoming a trusted regulatory partner, ensuring high-quality regulatory submissions, maintaining global product registrations, and proactively navigating evolving regulatory requirements. WHAT YOU WILL DO <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Prepare, compile, and submit regulatory documentation for new products and product changes, with a primary focus on Technical Documentation in accordance with EU MDR 2017/745</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Maintain global regulatory approvals and registrations, ensuring timely renewals, updates, and ongoing compliance</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Provide regulatory guidance and support to cross-functional teams, including R&D, Quality, Marketing, and Clinical Affairs throughout product development and change management activities</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Ensure compliance with applicable international regulations and standards, including FDA QMSR, EU MDR 2017/745, ISO 13485, and ISO 14971</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Monitor changes in global regulatory requirements and communicate potential impacts and recommendations to internal stakeholders</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Support internal and external audits and inspections, including interactions with regulatory authorities and notified bodies</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Maintain regulatory documentation, records, files, and databases in accordance with company procedures</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Collaborate with international partners to support global product registrations and regulatory submissions</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Contribute to regulatory activities that support product lifecycle management and continued market access</li> </ul> WHAT YOU WILL BRING <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Bachelor’s degree in a scientific, engineering, or related field</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">1–3 years of Regulatory Affairs experience within the medical device industry</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Knowledge of global medical device regulations, including U.S. FDA and EU MDR requirements</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Experience preparing regulatory submissions, including Technical Documentation and international registrations</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Strong written and verbal communication skills, with the ability to communicate effectively across multiple functions</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Excellent organizational skills and the ability to manage multiple projects and deadlines simultaneously</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Ability to work effectively in a fast-paced environment with changing priorities</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Experience with regulatory management systems or electronic quality management systems (eQMS) – an advantage</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Experience with Class II and/or Class III medical devices – an advantage</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Familiarity with Software as a Medical Device (SaMD) or active medical devices – an advantage</li> <li style="margin:0.0cm 0.0cm 0.0cm 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Master’s degree and/or Regulatory Affairs Certification (RAC) – an advantage</li> <li style="margin:0.0cm 0.0cm 8.0pt 24.0px;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Prior involvement in regulatory strategy development – an advantage</li> </ul> WHO YOU ARE <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Detail-oriented and highly organized, with a commitment to accuracy and quality</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Curious and proactive, with a desire to continuously learn and stay current with evolving regulatory requirements</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A collaborative partner who enjoys working across multiple disciplines and building strong working relationships</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Comfortable balancing multiple priorities while maintaining a high standard of execution</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Motivated by the opportunity to contribute to innovative medical technologies that improve patients’ lives</li> </ul> ABOUT NOVOCURE Novocure is a company with a powerful mission: to extend the lives of people living with some of the most aggressive forms of cancer. Here, your work will have a direct impact on patients and those who care about them. Join a team of passionate, collaborative people who support each other, challenge one another, and innovate together. Here, you’ll connect, grow, and make a real difference. We’re a company with the drive of a startup and the strength that comes with 25 years of success. Novocure operates at a rare crossroad, where advanced medical technology converges with cutting-edge biotechnology. We are the only company to develop and commercialize Tumor Treating Fields (TTFields), a proprietary, groundbreaking therapy designed to disrupt cancer cell division. With us you will find a unique combination of laboratory research work alongside engineering development of advanced technologies. This fusion of disciplines positions us as true pioneers in oncology innovation, leading a new frontier in the treatment of aggressive cancers. Our patient-forward values – innovation – focus – drive – courage – trust – empathy

Product Regulatory Affairs Specialist (Haifa, IL, 3508504) @ Novocure Inc

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