ASSOCIATE DIRECTOR REGULATORY AFFAIRS
Round Lake, IL
Req ID 49856BR
Business Title
Associate Director, Regulatory Affairs
Business
Medical Products
Sub-Business
Regulatory Affairs
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
•Innovative regulatory role supporting all new medical device development across Franchises for Medical Products.
•Responsible for establishing technical regulatory standards and submission content for medical device global submissions. Technical regulatory areas include biocompatibility, design verification and validation, sterilization, software verification and validation, human factors, self life testing, etc.
•Guide and influence R&D and quality to drive consistent interpretation of global standards and requirements.
•Support all Franchise regulatory teams for new medical device submissions, including global expansion. This includes working to develop global regulatory strategy for technical areas of submissions.
•Participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc)
•Initiate and maintain appropriate communication within the RA function globally and represent Regulatory Affairs with other functions
•Assess impact of new regulations and implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance
•Provide direct supervision of individuals including mentoring, performance management and staffing decisions
•Represent Baxter externally at appropriate industry associations
•May act as primary contact with regulatory authorities including the planning and leadership of meetings
•May participate in management of budgets
Job Requirements
•Sound basis of Scientific knowledge in multiple areas including medical device development, device verification and validation, software validation, human factors, biocompatibility testing
•Expert knowledge of globla regulations and standards, and experience with interpretation and application
•Excellent written and verbal communication, presentation, and facilitation skills•
•Strong negotiation skills and significant experience in interacting with regulatory authorities
•Risk identification and problem solving skills
•Demonstrated ability to lead, mentor, and develop others for future growth and development
•Established relationships with regulatory authorities
•Advanced degree or country equivalent in related scientific discipline with a minimum of 8 years experience in RA, including at least three years experience managing people.
•PhD will be an advantage.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
