Senior Specialist, Medical Devices
Medidata: Conquering Diseases Together
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,400 customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company, is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com.
Medidata Global Compliance and Strategy’s (GCS) mission is to help its stakeholders successfully navigate and interpret the global regulatory landscape thereby enabling Medidata’s clients to maximize the potential of the Medidata Cloud unified platform. The GCS team creates meaningful customer interactions through the application of a risk-based approach to continuously improving quality within the global regulatory landscape.
The Senior Specialist, Global Compliance and Strategy is responsible for performing business-related operations of the Global Compliance and Strategy (GCS) department, specific to the Medical Devices quality and regulatory functions. Primary job responsibilities include but are not limited to documenting a quality management system for devices (e.g. 510k, Software of a Medical Device), providing backup support for client audits and providing operational support to GCS-managed programs, as applicable. The position interacts with all levels of management and other personnel within Medidata, as well as with auditors and other representatives of Medidata’s clients and prospects.
Required practical experience related to life sciences regulatory landscape and associated Quality Management Systems for Medical Devices.
Strong familiarity and proven skills in the design and implementation of a Quality Management System related to Medical Devices; Software as a Medical Device preferred.
Provide operational support to GCS-managed programs, including:
Quality Incident (QI) management
Quality System Document management
Internal Quality System audit (in coordination with department-led operational self assessments)
Provide backup support for client audits, including:
Scheduling, preparing for, hosting, and following-up on client audits of Medidata
Coordination of audit responses and the preparation and delivery of Medidata’s audit response to external auditors
Assist GCS management with activities related to client regulatory inspections and internal audits; and regulatory inspections of Medidata itself
Respond to requests from other departments within Medidata related to quality and regulatory information and documentation for clients
Fulfill requests from GCS management related to the department’s business operations (e.g., metrics, status updates)
Moderate to expert knowledge of Microsoft Office suite
Effective interpersonal and verbal/written communication skills
Your Education & Experience:
College degree (Bachelors) or higher
Experience with Quality Management Systems for medical devices and/or software as a medical device
Experience with corrective and preventive action programs
2+ years experience in life sciences industry and/or medical/clinical operations strongly preferred;
Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development, enabling life-saving drugs and medical devices to get to market faster. Our products sit at the convergence of the Technology and Life Sciences industries, one of most exciting areas for global innovation. Nine of the top 10 best-selling drugs in 2017 were developed on the Medidata platform.
Medidata Solutions have powered over 17,000+ clinical trials giving us the largest collection of clinical trial data in the world. With this asset, we pioneer innovative, advanced applications and intelligent data analytics, bringing an unmatched level of quality and efficiency to clinical trials enabling treatments to reach waiting patients sooner.
Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.