Associate Director, Regulatory Affairs

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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 Baxters objectives in alignment with PSSs 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 youll 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 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.

What youll bring

• 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

We understand compensation is an important factor as you consider the next step in your career. At Baxter we are committed to equitable pay for all employees and we strive to be more transparent with our pay practices. The estimated base salary for this position is $00 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on upon location skills and expertise experience and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this our pay philosophy and available benefits please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident short-term and long-term disability and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount and the 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching. We also offer Flexible Spending Accounts educational assistance programs and 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 and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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