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RA (Regulatory Affairs) Lead

Neteera is a promising start-up company, developing a cutting-edge radar-based technology, for remote and contactless vital sign sensing solution in the healthcare industry.

We are seeking a dedicated and experienced Medical Device Regulatory Affairs Lead to support the development of regulatory strategies and compliance for our innovative medical device. In this role you will be working with various internal and external, national and international functions, reporting to the QA/RA/CA VP.

If you have experience in the medical device industry, preferably including software components - come grow with us.

The position is in Jerusalem.

Key responsibilities and tasks:

  • Guide cross-functional teams to establish and maintain regulatory processes, ensuring that our products meet global standards

  • Develop and implement comprehensive regulatory strategies/roadmap to ensure product compliance with US FDA CFR and EU MDR

  • Prepare and file regulatory submissions for the registration of medical devices

  • Update existing evaluations and technical files, including product risk management reports. Evaluation and approval of mechanical testing

  • Update technical files following changes and updates to the products

  • Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners

  • Collaborate with QA to ensure adherence to applicable ISO standards, such as ISO 13485 and ISO 14971 Risk Management for Medical Devices

  • Ensure that the organization is fully compliant with all relevant regulatory requirements and standards. Partner with QA to prepare for and manage regulatory audits as required

  • Actively participate in regulatory improvement initiatives, suggest process enhancements and engage with cross-functional teams to drive change

Professional skills:

  • Bachelor’s degree in a scientific discipline (Engineering/Life Sciences/Biotechnology)

  • Proven hands-on experience in Global Regulatory Affairs, including regulatory submissions and interactions within the medical device industry

  • Strong knowledge of US FDA CFR and EU Medical Device Regulation

  • Experience working with ISO 13485 and ISO 14971 Risk Management for Medical Devices

  • Experience with medical devices using Software (IEC 62304) – an advantage

Candidate Profile:

  • Proficiency in English

  • Attention to detail and a commitment to maintain high-quality standards with the ability to guide cross-functional teams through risk management processes

  • Creative problem-solving and decision-making abilities

  • Excellent communication and interpersonal skills to effectively interact with regulatory agencies and internal teams

  • Ability to adapt to evolving regulations and industry standards

If you have the necessary experience and qualifications for this position, we encourage you to apply.

Send your CV to:

hr@neteera.com

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