Senior Manager – Global Regulatory Affairs
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
As a Senior Manager – Global Regulatory Affairs, you will be responsible for defining global regulatory strategies and submissions in support of new and existing marketing authorizations for medical devices, focusing on software, for the Clinical Nutrition global business unit (GBU).
You will interface with key business and cross-functional stakeholders to ensure that the commercial objectives are achieved.Specific activities may include submission planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project teams.
This is an important individual contributor position within the Clinical Nutrition Regulatory Team, and you will be accountable for the relationship with the US Food and Drug Administration, along with other relevant regulatory bodies. You will provideinput and help influence global regulatory strategies and be responsible for the local execution of Baxter’s regulatory initiatives in line with business goals.
- Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with Baxter and external standards
- Assess impact of new regulations and provide feedback
- Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate risks
- Provide technical and strategic input for regulatory decisions 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
- May act as primary contact for meetings with regulatory authorities including planning and leadership
- Maintain appropriate communication within the RA function, with GBU Marketing, and with other functions primarily at the project team level
- Plan and manage complex projects and prioritize workload
- Initiate, manage and maintain operational activities in support of new and existing marketing authorizations
- May manage regulatory budget at project level
- May represent Baxter interests in industry and working groups
- Set team, group, or service objectives to assure they align with the regulatory strategy
- May provide direct supervision of individuals including mentoring
- Ability to work effectively in multinational/multicultural environment
- Technical and management skills
- Expert Regulatory knowledge
- Sound basis of Scientific (Training/ Communications) knowledge
- Ability to oversee multiple projects in a matrix team environment
- Excellent oral and written communication and presentation skills
- Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
- Ability to lead, coach, and motivate others
- Ability to accomplish results through others
- Bachelor’s degree or country equivalent in a scientific discipline
- Masters and/or PhD a plus
- Minimum 7 years of experience in Regulatory Affairs, including managing projects or people indirectly
- Concrete experience in the field of software as medical device in major markets including for instance USA and/or European Union
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.
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Job posted: 2021-02-03