Senior Regulatory Affairs Specialist

1 week ago


Thousand Oaks, United States Lifelancer Full time
Job Title: Senior Regulatory Affairs Specialist (USA - Remote)

Job Location: Thousand Oaks, CA, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Employer Industry: Medical Device Manufacturing

Why Consider This Job Opportunity

  • Salary up to $125,100
  • Potential for annual performance bonus and comprehensive medical/dental/vision benefits
  • 401K match and other applicable compensation plans
  • Opportunity for career advancement within a leading medical device company
  • Supportive and collaborative work environment with cross-functional teams

What To Expect (Job Responsibilities)

  • Independently plan and coordinate medical device regulatory submissions across various international markets
  • 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)

What Is Required (Qualifications)

  • Bachelor's Degree (BA/BS) 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

How To Stand Out (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

#MedicalDevices #RegulatoryAffairs #CareerGrowth #CompetitiveSalary #HealthcareIndustry

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Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https://lifelancer.com/jobs/view/524f9c82674d41d9445133f5b2290eeb

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