Regulatory Affairs Expert for Medical Device Manufacturing

7 days ago


Thousand Oaks, California, United States Lifelancer Full time

Job Opportunity: Senior Regulatory Affairs Specialist in Thousand Oaks, CA

We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team in Thousand Oaks, CA. As a key member of our regulatory affairs department, you will be responsible for planning and coordinating medical device regulatory submissions across various international markets.

Salary: $125,100 per year, with potential for annual performance bonus and comprehensive benefits

Job Responsibilities:

  • Independently plan and coordinate medical device regulatory submissions
  • Provide regulatory strategy and assess the impact of changes on existing products
  • Review and approve marketing communication materials while ensuring compliance with regulations
  • Support external audits and maintain communication with regulatory authorities regarding submissions
  • Create and update departmental standard operating procedures (SOPs)

Requirements:

  • Bachelor's Degree in Engineering, Life Sciences, or a healthcare-related discipline
  • 3-5 years of experience in medical devices regulatory submissions
  • Proven experience with 510(k) submissions and international registration processes
  • Strong organizational skills and ability to multi-task effectively
  • Proficient in MS-Office Applications and knowledge of quality system requirements

Preferred Qualifications:

  • Experience with FDA, Health Canada, and international regulatory agencies
  • Advanced degree and/or Regulatory Affairs Certification (RAC)
  • Strong communication skills with the ability to present information effectively
  • Experience in supporting international registrations and knowledge of medical device regulations
  • Ability to negotiate with regulatory agencies and solve regulatory issues

This is an exciting opportunity to work with a leading medical device company and contribute to the development of innovative products. If you have a strong background in regulatory affairs and a passion for ensuring compliance, we encourage you to apply.



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