Director - Regulatory Affairs - ACell - Columbia

Job description
The Director of Regulatory Affairs oversees all U.S. and international activities relating to strategies for regulatory submissions, clearances, and approvals.

Principal Responsibilities
Assume the lead in designing and executing regulatory strategies for timely and high quality submissions (e.g., 510(k)s, IDEs, PMAs, BLAs, foreign submissions, etc.) in close collaboration with the Marketing, Legal, Product Development, Manufacturing, and Clinical Affairs departments
Lead and coordinate interactions with regulatory agencies relating to regulatory submissions for clearances or approvals
Coordinate with the Legal department on the interpretation of regulations into practical and workable plans
Provide regulatory advice to other departments and executive management
Develop and manage the regulatory department budget
Participate in providing general training and management related to regulatory affairs


Desired Skills and Experience
Required Education and Experience
Bachelor’s degree in Life Sciences, Engineering, or Business (MBA, Master’s in a healthcare field, or J.D. helpful)
Minimum of 8 years of experience in medical device regulatory affairs; minimum of 5 years in a managerial position
Experience with Class II and Class III medical devices
Direct experience in writing IDE, 510(k), PMA, and international device/drug registrations
Experience with animal tissue/biomaterials desired
Experience with biologics and/or pharmaceuticals desired
RAC designation desired
Required Knowledge, Skills, and Abilities
Excellent attention to detail and recordkeeping
Excellent verbal and written communication skills
Demonstrable organization, prioritization, and problem-solving skills
Leadership, management, and negotiation skills
Strong interpersonal and team-building skills
Travel Requirement
Less than 15% travel required

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