Senior Regulatory Affairs Specialist USA - Remote

About the job Senior Regulatory Affairs Specialist (USA - Remote)
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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