Global Regulatory Affairs Sr Manager Medolla

Global Regulatory Affairs Sr Manager
Medolla
Emilia Romagna, Medolla

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support. **Summary

This is a great opportunity to be responsible for defining global regulatory strategies and submissions in support of new and existing marketing authorizations in a global business unit with focus on electromechanical devices.

You'll lead functional team working on electromechanical devices.

**What you'll be doing

- Provide technical and strategic input for regulatory decisions aligned with business strategy

- Identify and prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups

- 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

- 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, performance management and staffing decisions

**What you'll bring

- Bachelor/Master's degree or country equivalent in a scientific discipline (PhD will be an advantage)

- +7 years experience in RA, including managing people or projects

- Expert Regulatory knowledge in electromechanical devices

- Sound basis of Scientific (Training/ Communications) knowledge

- Ability to oversee multiple projects in a matrix team environment

- Ability to work effectively in multinational/multicultural environment

- Interest in Regulatory Intelligence and experience managing standard compliance and regulation updates

- Excellent oral and written communication and presentation skills

- Excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities

- Ability to lead, coach, and motivate others and to accomplish results through others

- Fluent English knowledge

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**Reasonable Accommodations

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