KPMG Manager, Regulatory Medical Device in Short Hills, New Jersey
Business Title: Manager, Regulatory Medical Device
Requisition Number: 67085
Area of Interest: Information Technology
City: Short Hills
The fastest growing Big Four professional services firm in the U.S., KPMG is known for being a great place to work and build a career. We provide audit, tax and advisory services for organizations in today's most important industries. Our growth is driven by delivering real results for our clients. It's also enabled by our culture, which encourages individual development, embraces an inclusive environment, rewards innovative excellence and supports our communities. With qualities like those, it's no wonder we're consistently ranked among the best companies to work for by Fortune Magazine, Consulting Magazine, Working Mother Magazine, Diversity Inc. and others. If you're as passionate about your future as we are, join our team.
KPMG is currently seeking a Manager in Technology Enablement for our Management Consulting practice.
Provide subject matter advisor support to clients related to the Medical Device Directive (MDD) - Directive 93/42/EEC and the draft EU MDR Law (European Medical Device Regulation)
Lead client workshops to determine future state processes needed to accompany medical device regulations
Educate clients in regards to the process and data requirements needed to successfully arrange government regulatory reporting capabilities for EU and U.S. medical device regulations
Articulate the detailed steps involved in performing a technology enabled regulatory transformation as it relates to regulatory submissions and health authority commitments
Identify the master data elements, supporting processes, and overarching governance principles required to maintain high regulatory data quality
Lead strategy and road mapping discussions related to achieving regulatory compliance across master data, labeling, QA, IT, and regulatory departments within a medical device company
A minimum of five years of project management experience within a regulatory medical device environment including but not limited to European medical devices; a minimum of three years of working in regulatory or QA of medical devices
Bachelor's degree in Business, Computer Information Systems or a related field from an accredited college/ university; certifications with relevant associated years of experience applying PMP, ITIL, TOGAF, and GxP is a strong plus
Exposure to Medical Device Directive (MDD) - Directive 93/42/EEC and experience with the European Parliament, European Council, or European Commission regarding medical devices (e.g. involvement in a working group)
Past involvement or time spent analyzing the new draft EU MDR Law (European Medical Device Regulation)
Experience with notified bodies, registrations to heath authorities, tracking ministry of health correspondence, and commitments
Exposure to post market surveillance, product labeling, and regulatory information management
Travel may be up to 80-100%
Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future
KPMG LLP (the U.S. member firm of KPMG International) offers a comprehensive compensation and benefits package. KPMG is an equal opportunity employer. All qualified applicants are considered for employment without regard to race, color, creed, religion, age, sex/gender, national origin, ancestry, citizenship status, marital status, sexual orientation, gender identity or expression, disability, physical or mental handicap unrelated to ability, pregnancy, veteran status, unfavorable discharge from military service, genetic information, or other legally protected status. KPMG maintains a drug-free workplace. KPMG will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable local, state or federal law (including San Francisco Ordinance number 131192). No phone calls or agencies please.