Director, Regulatory Affairs
RCRI, a provider of integrated services to the medical device and biosciences
industries, is seeking a Director, Regulatory Affairs.
This position develops and evaluates the success of the annual business
objectives for the Regulatory Department.
The Director, Regulatory Affairs actively participates or leads in the
marketing of services to existing and potential customers.
This position also serves as a senior strategic consultant for client’s
regulatory affairs/compliance matters and acts as a key liaison with customers,
regulatory bodies, and pertinent professional organizations (e.g., RAPS, ASQC,
etc.).
The individual serving in this position will be a member of the RCRI management
team. Responsibilities include initiation, implementation and management of
regulatory strategies, submissions and compliance activities that meet global
requirements. Duties include designing,
managing and/or writing regulatory submissions, and coordinating with clinical
affairs and biostatistics for support in comprehensive projects, mentoring
other RCRI staff, actively pursuing business development and new client
opportunities, and marketing RCRI services.
Qualified applicants will have a degree in a scientific or technical field, a
minimum of twelve years experience in regulatory affairs including project
management for Class II or Class III devices, excellent analytical and
qualitative skills, and a strong understanding of project management. RCRI offers a progressive work environment
including flexibility and comprehensive medical, dental, retirement and
profit-sharing benefits. Forward resume
with salary requirements to: hr@rcri-inc.com
RCRI, Inc. 5353 Wayzata Blvd., Suite 505, Minneapolis, MN 55416.
No phone calls, no agencies please. EOE
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