Regulatory Affairs Specialist

6 days ago

Yoqneam Illit North District, Israel Radix Engineering Full time $104,000 - $130,878 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.

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