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Regulatory Compliance Specialist
2 months ago
Location: Redondo Beach, 100% onsite
Shift: M-F, standard working hours
Pay: $40-$45/hr
Temp to Hire
Key Responsibilities:
- Collaborate with Global/Platform Regulatory Affairs, Research & Development, Clinical teams, and cross-functional partners to ensure adherence to regulatory standards.
- Facilitate discussions and partnerships to evaluate new health authority regulations.
- Support intricate projects, make informed decisions, and foresee regulatory challenges.
- Engage with Subject Matter Experts to gather essential information for regulatory submissions.
- Assist in the maintenance of global product registrations and audits.
- Prepare documentation for regulatory submissions and oversee FDA Certificates to Foreign Government.
- Initiate investigations for non-conformities and implement CAPA/SCAR processes.
- Bachelor's degree in a relevant field.
- 3-5 years of experience in regulatory affairs within the medical device sector.
- Familiarity with various jurisdictions including EU, US, and Asia.
- Experience with EU MDR technical documentation.
- Basic project management capabilities.
- Regulatory Affairs Certification is preferred.