Regulatory Compliance Specialist Lead

3 days ago


Thousand Oaks, California, United States Lifelancer Full time
About Us

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT that connects talent with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.

We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment.

Job Description:

This Senior Regulatory Affairs Manager position involves independently planning and coordinating medical device regulatory submissions across various international markets.

Responsibilities:

  • 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.

Benefits:

  • Potential for annual performance bonus.
  • Comprehensive medical/dental/vision benefits.
  • 401K match and other applicable compensation plans.

Estimated Salary: $125,100 per year.



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