QMS Regulatory Specialist

Job Overview
Serve as a primary thought leader and regulatory specialist for SmartSolve in the Life Sciences market, establish and actively drive the SmartSolve Enterprise Quality and Compliance Management Solutions into new and existing markets, and identify new solutions and industries to expand SmartSolve’s Enterprise Quality and Compliance Management footprint.

Job functions include
Sales and Revenue Support by developing industry focused demo verbiage, presentation materials, collateral, newsletter articles, blogs and white papers, and regulatory guidance to product.  Provide Industry & Regulatory training to the sales team, including the sales demo team as appropriate for their roles.  

Provide Regulatory and Market Requirements to the product team by tracking changes or additions in standards and regulations that impact SmartSolve and then monitoring those standards and regulations.  Provide quarterly regulatory updates to customers, liason with regulatory bodies to discuss compliance to regulatory reporting issues.  Serve as the company spokesperson regarding QMS regulatory compliance, and work with those responsible for selling, implementing and supporting SmartSolve to ensure their understanding of QMS regulations and their impact on SmartSolve.  

Additional duties include review of software requirements and design review, participation and contributions to Knowledge Transfers, serve as a trusted advisor to customers and provide customer support that is inclusive of regulatory compliance discussions, regulatory audit support.

Skill and Experience Requirement:
Master’s degree or Minimum of 10 years operational experience. RA certification.
The individual must possess strong skills in the following:
• Strong communication skills: verbal, written and interpersonal (English)
• Proven experience in documenting market requirements as input into development
• 8-10 years of experience in enterprise business applications and product marketing
• Domain Expertise in Life Sciences gained through operational and/or strategic consulting 
experience
• Strong team skills – especially in crossfunctional teams
• Strong relationship building and alignment skills
• Extensive experience in Relevant Industry ( Pharma & Medical Devices) with strong understanding of customer and market dynamics
English is the official language to use but other languages spoken will be an assett
Experience with SmartSolve Enterprise Quality and Compliance Management Solutions 
Experience in understanding of QMS regulations and their impact on SmartSolve

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.