Senior Regulatory Affairs Specialist
1 week ago
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
- 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)
- 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
- 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
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