Senior Regulatory Affairs Manager - Enabling Technologies

Must Have: Minimum Requirements

• Bachelor's Degree with 7+ years of experience in regulatory affairs in the medical device industry with roles showing increasing responsibility OR Advanced Degree with 5+ years of experience in regulatory affairs in the medical device industry 
• 5+ years of leadership experience as demonstrated through direct management and/or mentorship/advisory capacity 

Nice To Have

• Engineering or Advanced degree desired.
• Proven track record of leading high performing teams
• Ability to recognize and develop key talent
• Site leadership setting and executing various site specific regulatory and program initiatives
• Excellent knowledge of U.S. and European/International regulations, including EU MDR, and standards for all risk classifications of products
• Experience interacting with FDA and/or other regulatory agencies such as Q-sub preparations and meetings, submission issue meetings and other interactions
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Must work well in dynamic and cross functional team environments
• Must demonstrate collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities
• Proven analytical abilities and utilization of system tools such as electronic document control systems (e.g., Agile, Master Control), familiarity with SAP or other ERP system, experience with electronic management of regulatory affairs data
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology; experience with vascular therapies preferred
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing design specifications and other technical documents
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Documented evidence of writing skills
• Basic understanding of computer applications; proficient in Microsoft Office Applications
• Familiarity with medical terminology
• Some overnight travel required

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)

Travel up to 25%

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.

Learn more about our benefits:  benefits.medtronic.com

This position is eligible for a short-term incentive plan.  Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here.

Salary Min:$139,200.00          Salary Max: $208,800.00