QMS Regulatory Specialist (QMS Software)
IQVIA
Vienna, AT
vor 1 Std.
source : DirectEmployers Association

IQVIA â ¢ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.

Formed through the merger of IMS Health and Quintiles , IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

     Â                                           Why IQVIA Making a positive impact on human health takes insight, curiosity, and intellectual courage.

It takes brave minds , pushing the boundaries to transform healthcare. In your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and, ultimately, improve outcomes for patients.

IQVIA offers a competitive salary and great benefits , including a profit-related annual bonus, paid leave, and private health insurance.

Forge a career with greater purpose, make an impact, and never stop learning"Â Â Â Â Â Â Â Â Â Â Â Role Impact Working within a small global team, this role will give you the opportunity exercise your regulatory and consultative skills, providing regulatory expertise to a wide variety of internal and external SmartSolve stakeholders.

You will gain exposure in providing and influencing the direction of commercial off the shelf Quality management systems (QMS) software as a service (SaaS).

Job Overview You will be serving as a primary thought leader and regulatory specialist for SmartSolve in the Life Sciences market.

Establishing and actively driving the SmartSolve Enterprise Quality and Compliance Management Solutions into new and existing markets.

You will be identifying new solutions and industries to expand SmartSolveâ s Enterprise Quality and Compliance Management footprint.

Job responsibilities + Support Sales by aiding in the development of industry focused demo verbiage, presentations, blogs and white papers, and regulatory guidance to product.

Â+ Providing Regulatory knowledge transfers to the sales team, including the sales demo team as appropriate for their roles.

Â+ Providing Regulatory Requirements to the product team by tracking regulatory changes / additions and monitoring potential impacts to SmartSolve.

  • Liaison with regulatory bodies to acquire clarity on regulatory requirements Â+ Provide regulatory updates to customers virtually and via a quarterly newsletter+ As the SmartSolve spokesperson regarding QMS regulatory compliance, work with those responsible for selling, implementing, and supporting SmartSolve to ensure their understanding of QMS regulations and their impact on SmartSolve.
  • Â Â+ Work with Product Management on regulatory software requirements and design reviews, participating, and contributing to Knowledge Transfers.

  • Serve as a trusted advisor to customers, engaging in regulatory compliance discussions, regulatory audit support. Do you meet the skill, education, and experience requirements to apply to this role?
  • BSc in a scientific or related discipline at minimum, MSc would be desirable+ Extensive operational experience, usually demonstrated by 8 + years Regulatory affairs exposure or certification of competency,Â+ Strong Written and verbal communication skills in English is essential, other language+ Proven experience in documenting market requirements as input into development+ Experience with enterprise business applications including QMS+ Regulatory QMS Domain Expertise in Life Sciences gained through operational and / or strategic consulting+ Experience with SmartSolve Enterprise Quality and Compliance Management Solutions would be advantages.
  • At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible â 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 At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible â 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 IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare â and human health â forward.

    Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.

    Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled

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