Associate Principal Scientist – Device Risk Management Lead
MSD
full-time
Posted on:
Location Type: Hybrid
Location: Rahway • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $139,600 - $219,700 per year
Job Level
Senior
About the role
- Responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management
- Oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes
- Lead and contribute to thorough risk assessments for both inline and new products
- Develop and execute the device risk management strategy
- Ensure alignment with corporate policies and communicate effectively with cross-functional stakeholders and external suppliers
- Support Design Transfer activities
- Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management decisions and strategies
- Work collaboratively with cross-functional teams to embed risk management processes into the overall product development lifecycle
- Mentor junior risk management leads and cross-functional partners
- Prepare materials for program presentations for management review and regulatory submissions
Requirements
- B.S and Master's degree in Engineering, Science, Business, or a related field plus 8 years of related experience
- Minimum of 8 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area
- Strong knowledge of regulatory requirements and industry standards related to device systems
- Strong analytical and statistical skills with experience in data interpretation and risk assessment tools
- Excellent communication, leadership, and problem-solving skills
- Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.
- Combination Products
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
risk managementrisk assessmentsdata interpretationstatistical analysisregulatory requirementsquality managementdevice developmentpharmaceutical developmentdevice systems operationsrisk assessment tools
Soft skills
communicationleadershipproblem-solvingmentoringcollaborationorganizational skillsadaptabilityprioritizationcross-functional teamworkpresentation skills