Principal Regulatory Affairs Specialist - Cardiac Surgery (Hybrid)
PRINCIPAL 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 Principal Regulatory Affairs Specialist is responsible for developing strategies for worldwide governmental approval to introduce new products (Class II & III) to market, maintain existing products, provide advice on regulatory requirements, prepares worldwide submissions and negotiates their approval with the agencies. In addition, this position also assists with the training of other regulatory affairs staff and provides work direction on projects of large scale with significant business impact. This position will support worldwide regulatory activities associated with cardiac surgery products and therapies and also involves cross-functional interactions with other functions and mentoring of junior team members within the regulatory function.
A Day in the Life / Responsibilities:
- Define the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.
- Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products/therapies and changes to existing products. Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- Prepare regulatory (e.g., FDA/Notified Body) submissions for new products and product changes, as required, to ensure timely approvals. Review significant product submissions with manager and negotiate submission issues with agency personnel.
- Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.
- Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
- Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.
- Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
- Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.
- Provide feedback and on-going support to product development teams for regulatory issues and questions.
- Ensure personal understanding of all quality policy/system items that are personally applicable.
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- May mentor or supervise other RAS, as directed by manager.
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 7 years of experience in regulatory affairs in the medical device industry
- Or minimum 5 years of medical device regulatory experience with an advanced degree
Nice to Have (Preferred Qualifications):
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
- Experience with US submissions, EU MDR and other worldwide submissions and clearances.
- Original PMA experience is an added benefit.
- Experience performing advertising and promotion reviews for medical devices.
- Experience with FDA and international regulatory agency requirements.
- Effective interpersonal skills and team member.
- Ability to comprehend principles of engineering, physiology and medical device use.
- Experience with cardiac devices or therapies.
- Ability to effectively manage multiple projects and priorities.
- Proficient computer skills.
- Project management skills.
- Excellent oral and written skills.
- Excellent analytical thinking skills.
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, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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 here.
