We are working with a growing medical device client with a newly created position in their regulatory affairs department. This position will provide guidance to submissions personnel regarding operational procedures, manage submissions and will be responsible personnel hiring activities, manage training for new personnel, and cooperatively manage project allocations. The Regulatory Affairs manager will also maintain current knowledge of federal regulations, acts as consultant to other departments, participates in decision-making concerning policies, regulatory requirements and strategies, and manages external consultants as needed. Defines information and actions needed to meet requirements, prepares documents and/or submissions required to obtain clearance or approval from governmental agencies for legal commercial distribution of products.

REQUIRED: Four-year degree, preferably a Bachelor of Science degree. Management training and/or experience is required. A minimum of 5 years experience in Regulatory Affairs with 2 of these years in Submissions.

TO APPLY, after confirming that you meet the qualifications listed below, please send an email referencing this position title and location along with your resume and current/last base salary information to tonya@catgroupinc.com. This information will be kept confidential and will allow our team to better understand the level and direction of your search. Under no circumstances will we submit your resume without your approval.

Tonya Creamer
tonya@catgroupinc.com
803-622-5581
320-205-2266 (fax)
http://www.linkedin.com/in/tonyacreamer