QA/RA Manager Job at CSG Talent in San Diego

Key Responsibilities: Establish the strategy for all USA Regulatory and Quality Assurance activities Current account retention and growth, leading the implementation of entire USA QA/RA strategy The position will be involved in all phases of the complete line of products to ensure timely initial 510(k) clearance and compliance until end of the products commercial life cycle Will develop and maintain external relationships with key individuals and agencies that play critical roles in the FDA clearance process for all products, leading and direct high-quality, well-organized FDA submissions for new and existing products. Oversees all aspects of US based Quality Management System, specifically CAPA, Complaint and QMS compliance

Key Requirements: A proven track record in Quality Assurance and Regulatory Affairs across the USA in MedTech FDA management and 501(k) submissions experience with Class II devices Class II devices experience is essential, we cannot consider anyone without extensive experience in this area Quality Management Systems, CAPA and Post Market Surveillance experience The ability and experience to own and drive the entire QA/RA USA function independently USA citizen with the legal right to work in the USA without sponsorship Flexibility to regularly present in the office and manufacturing site in S California If the above is fits your experience and approach to sales/business development please apply and I will be in touch to discuss. Just as an immediate disclaimer I can only consider people who fit the exact description above, if you apply and don't fit the specification unfortunately I will not be able to consider you. CSG Talent are an equal opportunities employer working on behalf of the client. Seniority level Seniority level Entry level Employment type Employment type Full-time Job function Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at CSG Talent by 2x Sign in to set job alerts for “Quality Assurance Specialist” roles. Quality Assurance and Compliance Specialist IIManufacturing Quality Assurance Associate Quality Assurance Associate I – Document Control Call Center Quality Assurance Specialist Junior Quality Analyst – Quality Assurance Careers (Manual Tester) (39105) San Diego, CA $78,000.00-$92,700.00 18 hours ago National City, CA $28.00-$36.00 11 months ago Quality Control I/Lab (Required Flow Cytometry Exp) Entry Level - Urgent Need Quality Assurance Specialist (Compliance Specialist) Chula Vista, CA $28.00-$30.00 2 months ago Manual QA / R + D - Remote Work | REF#178383QA Manual Tester - Remote, Latin America Tijuana, Baja California, Mexico 1 month ago Sr Manager, Design Quality Assurance - Continuous Improvement (Hybrid) Ship/Submarine Quality Control 1 - San Diego, CAQA Inspector/Specialist I - Entry Level (Onsite) Exp in Life Sciences & Medical Device Quality Control I - Must Have Flow Cytometry and Flow Exp (Urgent Need) OnsiteWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.