Job title: Risk Management 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 Lead system-level risk management remediation initiatives to address gaps in risk integration, escalation, and decision-making across the organization.
Ø Conduct assessments of the risk management framework to identify structural gaps and develop remediation strategies aligned with regulatory expectations.
Ø Serve as the subject matter expert (SME) for ISO 14971, ensuring consistent interpretation and application of risk management principles across design and post-market activities.
Ø Strengthen integration of risk management outputs into QMS processes such as Management Review, CAPA, change control, and governance decision-making.
Ø Establish and implement risk escalation pathways, thresholds, and governance mechanisms to ensure critical risk information reaches appropriate leadership levels.
Ø Evaluate and remediate post-market risk management processes, ensuring complaints, trends, and nonconformances appropriately inform risk files and benefit-risk assessments.
Ø Develop and oversee risk remediation plans, cross-functional execution, and regulatory readiness, ensuring outputs are robust, defensible, and inspection-ready.
Ø 8+ years of experience in medical device risk management within a regulated environment.
Ø Demonstrated experience leading risk management remediation programs, particularly in response to regulatory findings or compliance gaps.
Ø Deep expertise in ISO 14971 risk management, including application across design controls and post-market risk activities.
Ø Proven experience integrating risk management into QMS governance and executive decision-making processes.
Ø Strong understanding of FDA regulatory expectations and global standards related to medical device risk management.
Ø Experience supporting regulatory inspections, audits, and remediation programs related to risk management findings.
Ø Strong leadership, communication, and stakeholder management skills, with the ability to translate complex risk information into actionable insights for senior leadership.
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