Associate Director, Regulatory Affairs-Front Line Care

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your Role At Baxter
This role will be responsible for global strategic planning of the portfolio within a business unit including development, implementation and management of plans and standards. Lead, mentor, and developsothers in service of Baxter's objectives in alignment with FLC’s Cardiology and Respiratory Health segments. Responsible for all aspects of regulatory strategy for the respiratory health and diagnostic cardiology product segments.  Provide quarterly regulatory intelligence impact assessments for SNG, STP and MKE. Oversee Notified Body consolidation activities for cardiology and respiratory health.  Mentor staff for 510(k) submissions, EU MDR submissions, MDD certificate extensions, Life 2000 EUA transition plan and multiple RH and Cardiology 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 
• 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 provide direct supervision of individuals including mentoring, performance management and staffing decisions

What you'll bring

• Masters and/or PhD will be an advantage. 
• Minimum of 8-year experience in RA, 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

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.

We understand compensation is an important factor as you consider the next s