Associate Director, Regulatory Affairs

• Responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards
• Leads, mentors, and develops others in service of Baxter's objectives in alignment with PSS’s hospital bed segment
• Participates in strategic LRP and AOP for Hospital Beds
• Responsible for all aspects of regulatory strategy for the PSS hospital bed product segment
• Provides quarterly regulatory intelligence impact assessments for Batesville, IN site
• Oversee Notified Body consolidation activities for the PSS hospital bed group
• Lead regulatory efforts for consistent delivery of CCS business objectives
• regulatory policy and implementation
• and identification and prioritization of key opportunities and risks
• Mentors staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, and NPD and sustaining projects
• Provide regulatory strategy for the site consolidation and site transfers

• Bachelors Degree required, or country equivalent
• Masters and/or PhD will be an advantage
• Minimum of 8-year experience in RA or related medical device function, including at least 3-year experience managing people
• Ability to work effectively in multinational/multicultural environment
• Management skills
• Sound basis of Scientific (Training/ Communications) knowledge
• Expert knowledge of regulations, 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
• Established relationships with regulatory authorities
• Demonstrated ability to lead, mentor, and develop others for future growth and development
• Risk identification and problem-solving skills

Masters and/or PhD

• Medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits