BioTalent
Director Quality Assurance Regulatory Affairs
BioTalent, Carlsbad, California, United States, 92002
Director Quality Assurance Regulatory Affairs
This role provides strategic leadership and oversight of compliance, regulatory, and quality activities for breakthrough medical technologies, ensuring patient safety, regulatory success, and operational excellence. Key Responsibilities: Act as
Management Representative
of the Quality Management System (QMS), ensuring compliance with
ISO 13485, FDA Quality System Regulation (QSR) , and global standards for sterile implantable and electronic devices. Lead
Risk Management
activities per
ISO 14971 , guiding the Risk Management Team in assessing product changes and monitoring design/development activities for compliance with design controls. Manage
internal audits , post-market surveillance, regulatory notifications, and customer communications related to complaints and investigations. Define regulatory pathways for new products and product changes (e.g., Letter to File,
510(k)
submissions). Coordinate with regulatory consulting partners to prepare and execute
510(k) submissions for Class II devices . Oversee management of
Nonconforming Materials (NCMR) , Corrective and Preventive Actions (CAPA), and supplier qualification metrics. Guide creation and implementation of
inspection and test methods , improving manufacturing quality, product assembly, and inspection integrity. Qualifications: Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred). 10+ years in the medical device industry , with at least 5 years in a leadership role. Deep knowledge of
FDA/QSR, ISO 13485, ISO 14971
and related international standards. Experience leading
510(k) preparation
and submissions for Class II devices. Technical proficiency in
MS Office, Matlab, PLM systems (Agile) , and application of statistical techniques. Strong interpersonal, leadership, and communication skills to influence across departments and drive compliance. We are an equal opportunities employer and welcome applications from all qualified candidates.
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This role provides strategic leadership and oversight of compliance, regulatory, and quality activities for breakthrough medical technologies, ensuring patient safety, regulatory success, and operational excellence. Key Responsibilities: Act as
Management Representative
of the Quality Management System (QMS), ensuring compliance with
ISO 13485, FDA Quality System Regulation (QSR) , and global standards for sterile implantable and electronic devices. Lead
Risk Management
activities per
ISO 14971 , guiding the Risk Management Team in assessing product changes and monitoring design/development activities for compliance with design controls. Manage
internal audits , post-market surveillance, regulatory notifications, and customer communications related to complaints and investigations. Define regulatory pathways for new products and product changes (e.g., Letter to File,
510(k)
submissions). Coordinate with regulatory consulting partners to prepare and execute
510(k) submissions for Class II devices . Oversee management of
Nonconforming Materials (NCMR) , Corrective and Preventive Actions (CAPA), and supplier qualification metrics. Guide creation and implementation of
inspection and test methods , improving manufacturing quality, product assembly, and inspection integrity. Qualifications: Bachelor’s degree in engineering, life sciences, or related field (advanced degree preferred). 10+ years in the medical device industry , with at least 5 years in a leadership role. Deep knowledge of
FDA/QSR, ISO 13485, ISO 14971
and related international standards. Experience leading
510(k) preparation
and submissions for Class II devices. Technical proficiency in
MS Office, Matlab, PLM systems (Agile) , and application of statistical techniques. Strong interpersonal, leadership, and communication skills to influence across departments and drive compliance. We are an equal opportunities employer and welcome applications from all qualified candidates.
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