QA/RA Manager

Proclinical is seeking a QA/RA Manager for a leading medical device company located in California. The Regulatory Affairs QA Manager is a hands-on working manager that will lead the day-to-day operational activities of the department and ensure that the project/s, department milestones and goals are met. This position is based at the company's headquarters in Palo Alto, CA. But is intermittently remote until our offices are open.

Job Responsibilities:

• Oversee the regulation process for products requiring governmental approval and handling all domestic and international government interactions.
• Obtain regulatory approvals and certifications for the company as and when necessary; 510(k)'s, ISO 9001, ISO 13485, QSR, CE and foreign government regulatory approvals.
• Facilitate external inspections, audits and investigations; FDA (Fed and State), KFDA, ANVISA, etc., as well as TUV, EHS, fire department, etc., to ensure regulatory compliance.
• Perform internal audits annually and whenever necessary to ensure continued regulatory compliance.
• Coordinate the inspection of the organization and contract facilities to ensure regulatory compliance.
• Generate CHRH product reports and maintain CDRH annual reports and VA quarterly reports.
• Process clinical complaints and maintain customer service and clinical complaints files for USFDA, EU-MDR, and regulatory reporting.
• Generate regulatory procedures as necessary to efficiently operate the business.
• Generate and maintain all DHF's, including facilitating risk management, design reviews and formal product transfer.
• Has full authority for personnel actions.
• R & D efforts and direct product transfer to manufacturing.
• Able to work cross-functionally with other departments to understand the requirements that require support.
• Improve manufacture of existing products by streamlining and automating processes where necessary.
• Provide leadership to assure that products meet quantity, cost, quality and regulatory objectives.

Skills and Requirements:

• Direct experience with 510(k)'s, De Novo, IDE, CE, ANVISA, COFIPRIS, TGA, HC, MFDS, NMPA, PMDA, TFDA, etc. highly desirable.
• Requires ten years of experience in the related area as an individual contributor.
• Requires a bachelor's degree
• 2 to 4 years of supervisory experience is required.
• A technical degree is preferred but not required.

If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or f.gbadamosi@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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