Job Description

Join to apply for the Regulatory Affairs Specialist role at Hemosure Continue with Google Continue with Google Join to apply for the Regulatory Affairs Specialist role at Hemosure About Us We are a leading In Vitro Diagnostic (IVD) manufacturer committed to delivering high-quality diagnostic solutions worldwide. We are seeking a dedicated and detail-oriented QA Assistant to join our team and support our quality assurance processes to ensure compliance with regulatory requirements and international standards. About Us We are a leading In Vitro Diagnostic (IVD) manufacturer committed to delivering high-quality diagnostic solutions worldwide. We are seeking a dedicated and detail-oriented QA Assistant to join our team and support our quality assurance processes to ensure compliance with regulatory requirements and international standards. Key Responsibilities Regulatory Submissions: Prepare and submit regulatory applications (e.g., IND, NDA, ANDA, BLA, MAAs, 510(k), CE Mark) to agencies such as the FDA, EMA, or other global authorities. Compliance: Ensure company products comply with regulations and quality standards throughout the lifecycle (development, approval, marketing, post-market). Regulatory Strategy: Collaborate with cross-functional teams (R&D, clinical, quality, manufacturing) to develop regulatory strategies that support product development and approval timelines. Communication: Serve as the liaison between the company and regulatory authorities, responding to inquiries and facilitating audits or inspections. Documentation: Maintain regulatory files, labeling, and records. Prepare summaries, technical files, and risk assessments. Monitoring: Stay up to date with changes in regulatory legislation and guidelines, and advise internal teams on impact and compliance. Labeling & Advertising Review: Review and approve product labeling, packaging, and promotional materials for regulatory compliance. Post-market Surveillance: Support post-approval product monitoring, adverse event reporting, and regulatory reporting obligations. Qualifications Education: Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field (Masters or PhD preferred for advanced roles). Experience: 1?5+ years in Regulatory Affairs, depending on role level. Familiarity with FDA, EMA, MHRA, PMDA, or global regulatory bodies. Preferred Qualifications Multi-lingual proficiency in both Mandarin Chinese and English at a professional level. Benefits Competitive salary and benefits package. Opportunities for professional growth and development. Collaborative and dynamic work environment Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Legal Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Hemosure by 2x Get notified about new Regulatory Affairs Specialist jobs in Baldwin Park, CA . Los Angeles Metropolitan Area $75,000 - $90,000 3 weeks ago Associate/Sr. Regulatory Affairs Associate Orange County, CA $80,000.00 - $100,000.00 2 weeks ago Manager, Regulatory Affairs (MLR Coordinator) Pasadena, CA $150,000.00 - $175,000.00 2 weeks ago Pasadena, CA $120,000.00 - $170,000.00 2 weeks ago Burbank, CA $95,000.00 - $135,000.00 2 days ago Director, Local Regulatory & Production Policy Los Angeles, CA $120,000.00 - $140,000.00 4 weeks ago Global Privacy Counsel, Regulatory Investigations Los Angeles, CA $133,000.00 - $228,000.00 18 hours ago Regulatory Specialist, Electrification and Customer Services Staff Quality Specialist - Regulatory Compliance Orange County, CA $123,000.00 - $160,000.00 1 week ago Los Angeles, CA $75,800.00 - $96,000.00 17 hours ago Diamond Bar, CA $80,033.56 - $110,526.56 1 hour ago Regulatory & Cmplnce HC Spec 3- Tumor Registry- FT Day Shift Regulatory & Cmplnce HC Spec 4 - Cancer Center- Stem Cell Clinc - FT Days Food Safety and Regulatory Affairs Manager Quality Control Specialist - 3rd Shift $1,500 Sign-On Bonus Regulatory & Cmplnce HC Spec 4 - Cancer Center- Stem Cell Clinc - FT Days Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Hemosure

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Full time, Local area, Worldwide, Relocation package, Night shift, Day shift,

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