Regulatory Affairs Manager
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About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Must Have: Minimum Qualifications
- Bachelor’s Degree in scientific discipline, advanced degree
- Minimum 5 years in Regulatory Affairs or Advanced Degree with a minimum of 3 years prior relevant experience
- Minimum of 3 years of managerial experience
- Demonstrated experience with submission to the European Union
- Excellent written and oral communication skills
- High Level of proficiency using MS Excel and MS Word.
- Working knowledge of MS Access, MS Project, and Adobe Acrobat Pro.
- High learning aptitude and adaptability with software systems
- Demonstrated technical writing skills.
- Experience managing employees
Nice to Have
- RAC credential preferred.
- Demonstrated leadership qualities
- A track record of developing and mentoring talent
- Ability to manage small scale projects to completion within and outside of the direct department.
- Excellent organizational and multi-project management skills and attention to detail
- Multi-tasks and prioritizes effectively in fast-paced environment
- Highly self-motivated, organized, detail oriented, and efficient.
- Team player who seeks to help and learn from colleagues seeing the department success as their own
- A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
- Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
- Proactively seeks to develop and become well-versed within in the regulatory landscape.
- Computer literacy, proficiency in MS Word, Excel, PowerPoint, etc
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
