Job title: Design Control Lead
About Us
Vaisesika is an ISO 27001 certified innovative and value driven company in the business of Software Development, Quality Engineering, Validated Testing, ERP services, Cloud Migration & DevOps, RPA, Data Analytics & Business Intelligence. We have offices in USA, Canada, India and UAE. We have been able to work in multiple projects in various domains ranging from Healthcare & Lifesciences, BFSI, e-commerce, Retail and we pride ourselves as one of the industry leaders in these areas.
Responsibilities
Ø Serve as Design Control Remediation Sub-Workstream Lead, providing technical direction, escalation management, and decision support for Design History File (DHF) remediation activities.
Ø Lead execution of design control remediation activities, ensuring alignment with remediation plans, procedures, and program objectives.
Ø Own and manage CAPAs related to design control observations, ensuring corrective actions are effectively implemented and sustained.
Ø Oversee cross-functional teams executing remediation workstreams, ensuring deliverables, timelines, and quality standards are met.
Ø Ensure effective integration between design controls and risk management, collaborating closely with risk management workstream leadership.
Ø Evaluate and remediate the application of ISO 14971 risk management principles across design control processes and deliverables.
Ø Support regulatory readiness, including preparation for audits and inspections, and ensure remediation documentation is robust, defensible, and inspection-ready.
Ø 8+ years of experience in medical device design controls within a regulated environment.
Ø Demonstrated experience leading design control remediation initiatives, particularly in response to regulatory findings or compliance gaps.
Ø Deep knowledge of medical device quality and regulatory standards, including FDA QMSR, ISO 13485:2016, and design control requirements.
Ø Strong expertise in ISO 14971 risk management, including integration of risk management activities into design controls and product lifecycle processes.
Ø Proven experience integrating design controls, risk management, and post-market inputs across complex product systems or product platforms.
Ø Experience supporting regulatory inspections, audits, and remediation programs, including regulator-facing documentation and responses.
Ø Strong leadership, communication, and stakeholder management skills, with the ability to influence cross-functional teams and senior leadership.
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