Principal Regulatory Affairs Specialist - REMOTE
- Bachelors degree in a scientific or engineering discipline
- Minimum of 7 years of experience in the medical device industry with Regulatory Affairs/Quality Assurance
- OR an advanced degree with a minimum of 5 years of experience in the medical device industry with Regulatory Affairs/Quality Assurance
- Product experience including implantable products (catheters preferred) and/or dialysis therapies
- Experience with software systems such as Agile
- Medical device Regulatory experience
- Working knowledge of global medical device regulations, including submissions.
- Demonstrated Microsoft Word, Excel and Adobe software skills.
- Experience working with cross-functional teams.
- Experience working with technical documentation/STED.
- Effective verbal and written communication skills.
- Experience with solving problems and concerns.
- Experience with project management and adherence to time schedules.
- Work well under pressure in a dynamic environment.
- Ability to multi-task effectively in a fast-paced environment
- Highly organized, detail-oriented, and efficient.
- Team player who seeks to help and learn from colleagues seeing the department success as their own
- Ability to manage small-scale projects to completion within and outside of the direct department.
- Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
- Proactively seeks to develop and become well-versed within the regulatory landscape.
- Regulatory Affairs Certification
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)