Regulatory Affairs Director

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.


SUMMARY
The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the Infusion Systems business unit of Medication Delivery, including development, implementation and management of global plans and standards. The position will direct and manage a team of regulatory professionals responsible for licensing of new products as well as life cycle management of existing products, including all US submissions (510(k)s/PMAs/IDEs). Accountable for relationship and communication with Regulatory Authorities, as well as business management and affiliates.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of Baxter
Ensure alignment of regulatory strategy to business strategy across all functional areas
Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Act as business liaison to the Infusion Systems Business Unit
Develop and manage budget
Act as primary contact with the regulatory authorities including the planning and leadership of meetings


Qualifications
QUALIFICATIONS

Sound basis of Scientific (Training/Communications) knowledge
Expert knowledge of medical device regulations, standards, current industry practices, and strong experience with interpretation and application. Experience with hardware/software medical devices required.
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Extensive familiarity with Industry and knowledge of forces impacting function
Risk management and problem solving skills
Ability to lead, mentor, and develop others for future growth and development
Established relationships with regulatory authorities (FDA)



EDUCATION AND EXPERIENCE
Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred.

As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits.




To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V