Principal Consultant, Quality and Compliance Services, Medical Device Consulting Services
Quality and Compliance Services is mainly focused on Medical Device/ In-Vitro diagnostic and pharma quality consulting. The group provides consulting services for external clients and provides support to internal technology services (e.g. SmartSolve). The scope of services covers the whole product cycle from product concept to post-market commercialisation.
The successful candidate will work with the Principal, QCS and other project leaders to deliver projects on time and to budget. This is a new post created to support clients and the IQVIA organization in understanding the current compliance trends in the Medical Device market and identifying consulting opportunities linked to market developments.
The candidate must be able to work with clients to apply their knowledge to:
• Develop Quality Strategy and implement requirements to take into consideration the regulatory needs in the region/country where the client is operating.
Required knowledge, skills and abilities:
Knowledge of Medical Device and In-vitro diagnostics market; ex FDA preferred and industry consulting experience
Ten years' experience in medical device or in-vitro diagnostics applying Quality Management Systems (21CFRPart820, ISO13485:2016, MDSAP)
Knowledge of medical devices and IVD diagnostics , including the changing global regulatory requirements
Knowledge of regulatory and QA requirements applied to the business environment.
The candidate must be able to work with clients to apply their knowledge to:
Works directly with clients to provide value added input on their strategic issues, identifies additional business development opportunities, and manages commitments for services delivery, managed service for client projects.
Essential Functions
• Serves as primary owner of client engagements, focusing on client satisfaction and delivery quality
• Supports proposal development
• Manages client interface and project team for efficient and effective project delivery
• Serves as solutions-based expert applying consultative problem-solving skills
• Identifies and develops new business opportunities
• Contributes to the enhanced awareness of IQVIA Quality Compliance Solutions
• Possesses business development skills and has broad knowledge of the industry to identify market trends and develop associated offerings
• Works willingly and effectively with others in and across the organization to accomplish team goals
• Knowledge of current and developing regulations/standards and applying them to Quality Compliance projects
• Knowledge and understanding of the marketplace and professional/trade associations key people and companies
• Demonstrated strategic thinking and planning and change management skills
• Excellent interpersonal and networking skills
• Values people's opinions and encourages knowledge sharing
• Able to manage complex relationships and juggle priorities
• Has excellent client relationship and influencing skills
Qualifications
• Bachelor's Degree Required
• Master's Degree Preferred
• Ex FDA Preferred
• >5 years experience in medical device consulting
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status