Regulatory Affairs Project Manager

1 week ago


Santa Clara, United States Tek Support Full time

We are seeking a Regulatory Affairs Project Manager to oversee and coordinate regulatory activities for our medical devices. The role involves planning, preparation, and submission of regulatory strategies and submissions to the FDA and international agencies, ensuring compliance and supporting market entry of instrument hardware and software.


Key Responsibilities:

  • Prepare and submit documentation for global regulatory registration.
  • Review product and manufacturing changes for regulatory compliance.
  • Serve as a regulatory representative on product development teams, providing guidance and expertise.
  • Maintain up-to-date knowledge of international medical device regulations.
  • Interface with FDA and other regulatory agencies as needed.
  • Support product release processes and review protocols for regulatory submissions.
  • Ensure compliance with FDA, international regulations, QMS, and EMS requirements.


Qualifications:

  • Bachelor's degree in Life Sciences, Engineering, or a related field.
  • Experience with US and international medical device regulations and quality standards.
  • Proficiency in MS Office Suite.
  • 5+ years of Regulatory Affairs experience in the medical device industry (preferred).
  • Experience with 510(k) submissions, software/instrument submissions, and design planning (preferred).


Skills:

  • Strong technical/medical writing skills.
  • Excellent verbal and written communication skills.



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