Senior Principal Regulatory Affairs Specialist - Remote

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Works independently to provide strategic input and technical guidance on regulatory requirements for business-critical and new product development projects

• Prepares pre-sub, IDE/IDE supplements, PMA/PMA supplements, 510(k), and MDR submissions.

• Direct interaction with FDA and Notified Body on defined matters.

• Provides guidance, coaching, and training to other employees

• Reviews Regulatory Strategies/Plans and Submissions and ensures consistency and alignment across multiple projects.

• Review promotional and advertising material

• Keeps abreast of regulatory requirements and changes.

• Actively seeks opportunities for improvement and drives new process solutions/systems across the Organization.

• Participate in internal and external audits as needed.

Required Knowledge and Experience: 

.
Requires a Baccalaureate degree

Minimum of 10 years of regulatory affairs experience or advanced degree with a minimum of 8 years of experience.

Nice to Have:

• Experience with Neurovascular Aneurysm Therapy devices and Class III implants in the US and EU

• SME in IDE, PMA, and Pre-Sub  

• Ability to be flexible with changing priorities

• Hybrid work model- 3 days onsite

• Excellent written and oral communication

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

Salary ranges for U.S (excl. PR) locations (USD):$152,000.00 - $228,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply to others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days. 

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