Regulatory Affairs Specialist

1 week ago

Yoqneam Illit North District, Israel Radix Engineering Full time ₪90,000 - ₪120,000 per year

Regulatory Affairs Specialist – Medical Devices


Location:
Yokneam Illit |
Full-Time Position

A global medical device company is seeking a talented Regulatory Affairs Specialist to join its team and take part in managing regulatory processes for cutting-edge medical device solutions across international markets.

Key Responsibilities:

  • Manage product registration processes and regulatory changes in global markets.
  • Develop and implement regulatory strategies in collaboration with the RA team.
  • Prepare and submit regulatory documentation to international health authorities.
  • Manage regulatory communications with clients and regulatory bodies.
  • Maintain and update regulatory databases, document management systems, and digital tools.
  • Prepare for and support internal and external regulatory audits.
  • Ensure compliance with relevant regulations and internal procedures.

Requirements:

  • Bachelor's degree in Engineering, Physical Sciences, or Biology.
  • 2-4 years of experience
    in regulatory affairs, preferably in the medical device industry.
  • In-depth knowledge of
    FDA regulations and/or CE Marking requirements
    .
  • Strong analytical, problem-solving, and project management skills.
  • Excellent communication skills in both Hebrew and English.
  • Proficiency in
    MS Office
    and
    SharePoint
    .

This is a great opportunity to join a dynamic and innovative company and contribute to the development of advanced solutions in the medical device industry.

  • Regulatory Affairs Manager

    2 weeks ago

    Yoqneam Illit, North District, Israel Radix Engineering Full time ₪90,000 - ₪120,000 per year

    We are searching for the best talent for a Regulatory Affairs Manager role, to join our team located in Yokneam, Israel.Purpose:In this role, you will oversee the management and execution of regulatory strategies and procedures to ensure the release of our products in compliance with regulatory requirements and standards.You Will Be Responsible ForDevelop...

  • Regulatory Affairs Manager

    2 weeks ago

    Yoqne‘am ‘Illit, Northern District, Israel Johnson & Johnson Full time ₪120,000 - ₪360,000 per year

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...

  • Regulatory Affairs Specialist, International RA

    3 days ago

    Yoqne‘am ‘Illit, Northern District, Israel Johnson & Johnson Full time ₪60,000 - ₪120,000 per year

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Regulatory Affairs Specialist II, Dangerous Goods Transportation

    5 days ago

    Nazareth, North District, Israel myGwork - LGBTQ+ Business Community Full time ₪60,000 - ₪90,000 per year

    This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionOverview:The Regulatory Affairs Specialist II is responsible for ensuring...

  • Senior Regulatory Affairs Program Lead

    2 weeks ago

    Yokneam, Haifa District, Israel Johnson & Johnson Innovative Medicine Full time ₪120,000 - ₪240,000 per year

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...

  • Senior Regulatory Affairs

    2 weeks ago

    Petah Tikva, Center District, Israel Align Technology Full time ₪90,000 - ₪120,000 per year

    Department:QualityLocation:EMEA-IsraelDescriptionAbout this opportunityIn this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partnersKey...

  • Regulatory Affairs Manager

    2 weeks ago

    Netanya, Center District, Israel Eitan Medical Full time ₪90,000 - ₪120,000 per year

    Eitan Medicalis a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care -from the hospital to the home.Job Description:Managing the post market RA team which handles the following activities:· Support design and post market compliance of products from a...

  • Quality System Senior Specialist

    2 weeks ago

    Yoqneam Illit, North District, Israel Medtronic Full time ₪89,600 - ₪134,400 per year

    We anticipate the application window for this opening will close on - 1 Nov 2025At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeMedtronic seeks a...

  • Regulatory Affairs Manager

    1 week ago

    Petah Tikva, Center District, Israel Medomie Full time ₪90,000 - ₪120,000 per year

    In this role, you will take ownership of regulatory submissions and approvals in Israel, managing the end-to-end registration process for innovative medicines, generics, and established molecules. You will serve as the key contact with the Ministry of Health and other regulatory bodies, while working closely with internal teams to drive projects forward.What...

  • Medical Affairs Manager

    7 days ago

    Petah Tikva, Center District, Israel Medison Pharma Full time $70,000 - $120,000 per year

    Medison offers hope to patients suffering from rare and severe diseases by forming partnerships with emerging biotech companies to accelerate access to highly innovative therapies in international markets.As the creator and leader of the global partnership category in the pharma industry, we strive to be Always Ahead and work relentlessly to bring therapy to...