Regulatory Affairs Specialist - Cardiac Surgery (hybrid)
Regulatory Affairs Specialist - Cardiac Surgery (hybrid)
Cardiac surgery represents end stage treatment in the care continuum for many cardiovascular diseases and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio.
Key Technologies
- Surgical heart valves
- Cardiac OR solutions (e.g., blood management, cannulae)
- Extracorporeal life support
- Coronary artery bypass grafting (CABG) solutions
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
Careers that Change Lives
The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.
A Day in the Life / Responsibilities:
- Collaborate with Operating Unit Regulatory Affairs Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to address questions from regulatory agencies.
- Provide support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring regulatory agency review. Prepare submissions and reports for FDA or provide support and documentation for global submissions.
- Maintain proficiency in worldwide regulatory requirements. Obtain and distribute updated information regarding worldwide laws, guidelines, and standards.
- Establish and maintain good relationships within the RA department, cross functional teams and assist in developing and maintaining positive relationships with device reviewers through oral and written communications.
- Support regulatory compliance activities, including internal or external audits, post-market surveillance activities, etc. as needed.
- Support product development programs as an extended core team member.
- Assist in negotiations with the FDA or other regulatory agencies for assigned projects.
- Other tasks, as assigned.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelor’s degree required
- Minimum of 2 years of experience in regulatory affairs in the medical device industry
- Or advanced degree with a minimum of 0 years of experience in regulatory affairs in the medical device industry.
Nice to Have (Preferred Qualifications):
- Experience working with Class II/III medical devices
- Experience with regulatory support of clinical trials
- Experience with FDA requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards.
- Effective negotiation and written/oral communication skills.
- Effective interpersonal, organizational and time management skills.
- Effective and respectful team member.
- Detail-oriented
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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
