Baxter
Healthcare
AssociateDirector,RegulatoryAffairs
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“Associate Director, Regulatory Affairs at Baxter. Skills: Regulatory affairs, Submission strategy, Risk identification, Regulatory policy. Develop regulatory strategy. Implement regulatory strategy”
Industry & Context.
Risk identification; Problem-solving
What They're Looking For.
Must Have
Bachelors Degree required, 8-year experience in RA, 3-year experience managing people, Ability to work in multinational environment, Scientific knowledge, Expert knowledge of regulations, Experience with interpretation and application, Excellent written communication, Excellent verbal communication, Excellent presentation skills, Excellent facilitation skills, Negotiation skills, Experience interacting with regulatory authorities, Established relationships with regulatory authorities
Nice to Have
Masters or PhD advantage
What You'll Do.
Develop regulatory strategy
Implement regulatory strategy
Lead EU MDR submissions
Lead global submission strategy
Prioritize risk areas
Implement mitigation plans
Follow up on mitigation plans
Develop alternative courses of action
Anticipate regulator responses
Develop contingency plans
Initiate communication within RA
Maintain communication within RA
Represent RA with business units
Represent RA with other functions
Act as primary contact for meetings
Plan meetings with regulatory authorities
Lead meetings with regulatory authorities
Implement policies for compliance
Ensure ongoing compliance
Manage regulatory budget
Lead global regulatory strategy development
Lead global regulatory strategy planning
Lead global regulatory strategy implementation
Represent Baxter interests in industry
Represent Baxter interests in working groups
Guide technical groups
Influence technical groups
Assess impact of new regulations
Implement changes for new regulations
Lead development of company policy
Lead development of company positions
Negotiate with regulators
Negotiate with stakeholders
Make decisions with regulators
Make decisions with stakeholders
Participate in third party efforts
Provide direct supervision
Make staffing decisions
How You'll Work.
Team & Collaboration
Business units; Other functions; Regulatory authorities; Technical groups; Industry groups; Working groups
Communication Scope
Written communication; Verbal communication; Presentations; Facilitation
Process & Methodology
Strategic planning, AOP planning, LRP planning
Full Job Description
**This is where** your work makes a difference. 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. **Your role at Baxter** 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. **What you 'll be doing ** * 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
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