SENIOR REGULATORY AFFAIRS SPECIALIST
ABOUT THE COMPANY:
Our client is a global Medical Device company with a 50 year history of
success in the industry. With over 1000 employees, the organization
boasts an experienced management team, strong momentum in their various
product lines and an empowering corporate culture that is focused on
the professional development of it's employees. This is a strong
opportunity for someone that wants to put their drive and initiative to
work!
RESPONSIBILITIES:
Preparing regulatory submissions (i.e. PMA; PMA Supplements, etc.) for submission to the FDA.
Interfacing with the FDA on assigned projects.
Responding to FDA requests for additional information.
Keeping abreast of changes to the worldwide regulatory requirements and International Standards related to the company's products and processes.
Formally communicating regulatory initiatives or changes in the applicable medical device laws with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations.
Participate on the Compliance Review Board for the review and approval of promotional advertising and literature.
Overseeing maintenance of regulatory files to ensure the Company's compliance with regulatory requirements.
Supporting special research functions as requested.
Performs other duties as may be required by supervisor.
REQUIREMENTS:
Advanced degree in Engineering, Bioengineering, Life Science or related area.
Experience with interpreting regulations and assembling regulatory submissions for domestic and international product approvals.
Ability to work independently to complete regulatory submissions.
Technical writing skills a must.
Class III medical device experience.
Must have excellent verbal and written communication skills, analytical skills, teamwork and interpersonal skills.
Skilled in the conduct of research on the Worldwide Web for regulations, guidelines, standards, medical device information, etc.
RAC certification and familiarity with electronic submissions preferred.
CONTACT INFORMATION TO APPLY:
Mark Fitzpatrick, Practice Manager
Sterling Life Sciences
A division of Sterling-Hoffman Executive Search
p. 416-979-6701 x282
f. 416-979-3030
e.
www.sterlinglifesciences.com
Sterling-Hoffman Life Sciences is the premier recruitment firm in North
America for organizations involved in the research, clinical development, manufacturing and distribution of drugs and devices that
allow people to live healthier and more fulfilling lives. Our clients
include Novartis, Stryker, Quintiles and Baxter Healthcare – we also
work with many progressive mid-size and small private companies. Please visit www.sterlinglifesciences.com for more information on our practice.