We anticipate the application window for this opening will close on - 26 Aug 2025

 

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

As a Principal Regulatory Affairs Specialist at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies. You will provide strategic input and technical guidance to ensure our products meet evolving domestic and international regulatory requirements. This high-impact role involves leading regulatory submissions, maintaining compliance, and driving collaboration across teams to support product development and lifecycle management. Your expertise will directly influence patient access to life-changing therapies worldwide.

Key Responsibilities:

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering global regulations.
• Lead or perform coordination and preparation of regulatory documentation for submissions, internal audits, and regulatory inspections.
• Compile and manage submission materials for new approvals, license renewals, and annual domestic and international product registrations.
• Recommends changes to labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance.
• Monitor, evaluate, and enhance regulatory tracking and control systems for continuous improvement.
• Stay current on evolving global regulatory requirements, procedures, and standards.
• Directly interface with regulatory authorities as needed on defined topics.
• Participate in and support internal and external audits.
• Review and provide guidance on promotional and advertising materials to ensure compliance with regulatory standards.
• Apply in-depth knowledge of FDA regulations, EU Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other international regulatory frameworks.
• Demonstrate leadership and collaboration skills in a team environment, including coaching and mentoring of team members.
• Successfully manage multiple priorities while maintaining a strong problem-solving mindset and effective decision-making capabilities.
• Drive successful regulatory submissions and approvals in both the U.S. and EU markets.

Must Have: Minimum Qualifications

• Bachelor’s Degree with a minimum of 7 years of relevant experience OR
• Advanced degree with a minimum of 5 years of relevant experience

Nice to Have: Preferred Qualifications

• 7+ years of medical device regulatory affairs with roles showing increasing responsibility.
• Strong leadership and team management skills.
• Excellent communication and interpersonal skills.
• Ability to thrive in a fast-paced, collaborative environment.
• Experience with Notified Body audits.
• RAC credential preferred.
• Strong interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”.
• Ability to analyze and resolve non-routine regulatory issues using independent judgment.
• Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations.
• Proven ability to create or revise departmental procedures to enhance operational efficiency or align with evolving regulatory requirements.
• Experience working with a range of medical device classifications and technologies.
• Demonstrated expertise in developing regulatory strategies that support timely approval of clinical trial applications.

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 Conditi