Global Regulatory Affairs Sr Manager (Electromechanical devices)
Baxter
- Medolla, Modena
- Tempo indeterminato
- Full time
- 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
- 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