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Merck · 3 days ago

Senior Scientist, Device Risk Management Lead

Rahway, NJ

Full-time

Hybrid

Mid, Senior Level

$115K/yr - $180K/yr

6+ years exp

Merck is a leading pharmaceutical company, and they are seeking a Senior Scientist, Device Risk Management Lead to spearhead risk management efforts in combination product development. This role involves overseeing device risk management activities, collaborating with cross-functional teams, and ensuring compliance with industry standards throughout the product lifecycle.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

Responsibilities

Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept through commercialization and post-market evaluation

Develop and execute the device risk management strategy, including the creation of device risk management plans and reports, conducting system hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with corporate policies and communicate effectively with cross-functional stakeholders and external suppliers

Support Design Transfer activities to internal and external sites ensuring proper translation and implementation of risk control measures

Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management decisions and strategies

Utilize statistical methods to interpret risk data, providing clear and actionable recommendations rooted in empirical evidence

Work collaboratively with cross-functional teams to embed risk management processes into the overall product development lifecycle

Proactively identify and address project challenges, effectively communicating risk management strategies within the Device Development team and with external partners

Understand and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards

Lead risk management workshops and training programs, facilitating knowledge transfer for internal and external manufacturing sites to strengthen awareness of risk management principles across teams. Mentor junior risk management leads and cross-functional partners to promote best practices

Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness

Contribute to the development, implementation, and continuous enhancement of device risk management processes, procedures, and tools

Stay informed of regulatory changes and industry best practices to maintain the effectiveness and relevance of our risk management strategies, sharing this knowledge with others in the organization

Participate in the strategic development of the Device Risk Management function, contributing to team goals and initiatives

Qualification

Device risk managementRegulatory complianceStatistical analysisQuality managementRisk assessment toolsLeadership skillsCommunication skillsProblem-solving skills