Associate Director, Regulatory Affairs Job at Baxter (Deerfield)

Associate Director, Regulatory Affairs

Baxter

Location:
United States , Deerfield

Category:
IT - Administration

Contract Type:
Not provided

Salary:

176000.00 - 242000.00 USD / Year

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Job Description:

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Job Responsibility:

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
Develop and implement regulatory strategy aligned with business strategy
Lead FDA, EU MDR and global submission strategy
Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
Participate in identification of risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
Initiate and maintain appropriate communication within the RA function and represent Regulatory Affairs with business units and other functions
Act as primary contact for meetings with the regulatory authorities including the planning and leadership
Implement policies to ensure ongoing compliance with regulatory requirements
May manage regulatory budget at project level
Independently lead global regulatory strategy development, planning, and implementation for multiple complex programs and platforms
May represent Baxter interests in industry and working groups
Guide and influence technical groups in areas of product development
Assess impact of new regulations and implement appropriate changes as well as lead development of company policy and positions on draft regulation and guidance
Responsible for negotiating and decision making with regulators and stakeholders with complex and high-risk projects
May participate in potential and established third party efforts (i.e. Due diligence activities, joint ventures, etc.)
May provide direct supervision of individuals including mentoring, performance management and staffing decisions

Requirements:

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

What we offer:

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

Additional Information:

Job Posted:
May 10, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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