Director Quality Assurance & Regulatory Affairs at BioTalent Director Quality Assurance & Regulatory Affairs at BioTalent in San Leandro, California Posted in 6 days ago.

Type:

full-time

Job Description:

•Candidates must have hands-on regulatory submissions experience (510k, PMA, De Novo) We're looking for an experienced Regulatory Affairs and Quality leader to build out and run the compliance backbone for a newly launched medical device organization. This person will own risk management strategy, lead the quality management system, and act as the company's primary point of contact with regulatory bodies - working closely with R D, Clinical, and executive leadership to bring products to market and keep them there. Responsibilities Set direction and strategy for organizational risk management Lead regulatory strategy and manage submissions through to clearance Own quality system compliance, documentation, and audit-readiness Partner cross-functionally with R D, Clinical, and Operations to keep approvals on track Build and run post-market surveillance and monitoring processes Requirements Minimum of Bachelor's degree with 8+ years in quality/regulatory functions within medical devices (Class II or III) Proven success securing FDA clearance (510(k) and/or De Novo pathways) Experience setting up and managing a QMS Strong cross-functional leadership and program management skills Hands-on experience with ISO 13485 and

ISO 14971

compliance