Senior Regulatory Affairs Specialist


Israel HQ: 3 Rapaport St., Kfar Saba 4465141, Israel

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Posted Date: Aug. 02, 2022

CathWorks, based in Israel and Irvine, CA, is a fast-paced medical device start-up focused on digital health innovations to improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence (AI) and computational science to provide physicians with comprehensive physiologic information, enabling them to make better treatment decisions for their patients with coronary artery disease.

Recently, CathWorks entered into a strategic partnership with Medtronic to market and sell the FFRangio System globally. Medtronic is the global leader in medical technology and has more than 90,000 employees worldwide in more than 150 countries. The partnership with Medtronic will expand CathWorks’ footprint globally, enabling more patients to benefit from its revolutionary technology that is poised to disrupt the current coronary physiology market.

As the Senior Regulatory Affairs Specialist at CathWorks, you will be responsible for regulatory assessment of software design changes and for maintaining compliance with applicable competent authorities’ requirements. At CathWorks you will be working in a fast-paced start-up environment that inspires, challenges, and supports its employees to continually grow in their careers in a collaborative team culture. If you have the entrepreneurial drive and demonstrated ability to collaborate with a variety of stakeholders in an innovative environment, CathWorks is the place for you.

Job Responsibilities: expand_more

  • Responsible for regulatory assessment of software design changes to maintain compliance with applicable competent authorities’ requirement
  • Responsible for coordinating and preparing regulatory submissions’ content (510k, NoC, etc.)
  • Responsible for Technical File, DHF, and DMR maintenance
  • Responsible for management of PMS activities – preparation and maintenance of the PMCF, PSUR, CEP, and CER
  • Maintain Regulatory Compliance with new or modified guidelines, perform gap assessments and implement changes as needed.
  • Support and assist in QA projects and QMS maintenance

Requirements: expand_more

  • B.A or B.Sc. degree in a relevant field
  • At least five years of experience in QA&RA from a medical device company. Software included devices/SaMD – An advantage
  • Knowledge in FDA QSR, EU MDR, PMDA, UK requirements. ANZ and additional territories- An advantage
  • Proficient in Hebrew and English, written and verbal
  • Ability to coordinate/participate in numerous tasks projects in a fast-paced environment in an organized manner while meeting deadlines
  • Skillset that includes being driven and self-motivated, holding communication and interpersonal skills, being organized, and practicing time management

About CathWorks: expand_more

CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines AI and computational science to obtain physiologic information from routine angiograms (X-rays), eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with a quick and reliable intraprocedural physiologic assessment for the entire coronary tree, making it practical for every patient.  For more information on CathWorks, visit and follow @CathWorks on Twitter and LinkedIn

Equal Opportunity Employer: expand_more

CathWorks is an Equal Opportunity Employer. This company does not and will not discriminate in employment and personnel practices on the basis of race, sex, age, handicap, religion, national origin, or any other basis prohibited by applicable law. Hiring, transferring, and promotion practices are performed without regard to the above listed items.

Unless stated otherwise, all positions posted for CathWorks are not intended for or open to third party recruiters/agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.

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