Senior Regulatory Affairs Specialist - Cardiac Rhythm Management (hybrid)
Senior Regulatory Affairs Specialist - Cardiac Rhythm Management (hybrid)
Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.
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 Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Diagnostics products and External Pacemaker to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The specialist also assists with the license maintenance including renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.
A Day In The Life
- Prepare worldwide submissions for new products and their product changes as required to ensure timely approval for market release. Review significant regulatory issues with supervisor, as necessary, and resolve submission issues with Medtronic engineering partners, Medtronic Geography Regulatory partners, and regulatory agencies as needed.
- Prepare regulatory strategies/plans and worldwide compliance requirements. Provide on-going support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations.
- Provide business and product information to enable development of strategies and requirements, as well as communicate that information to the Project teams.
- Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
- Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
- Negotiate with international agencies, as needed. All significant issues will be reviewed with the supervisor.
- Participate in the project team meeting to plan strategies, including reviewing the various specifications and plans/reports, defining target market and distribution method, Medtronic requirements on testing, etc.
- Provide regulatory analysis of product portfolio and review with other functional resources, such as Marketing, Global Supply Chain, etc., to ensure Diagnostics and EPG portfolio is aligned with existing portfolio. Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
- Work under general supervision following established procedures. Independently determines and develops approach.
- Frequent inter-organizational contact and some external contacts.
- Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
- Provide training and support to other members of the department.
- Other tasks, as required.
Must Have; Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
- Bachelor’s degree in a technical discipline
- Minimum 4 Years of medical device regulatory experience with Bachelor’s degree
- Or minimum 2 Years of medical device regulatory experience with an advanced degree
Nice To Have
- Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and PMDA), and working with cross-functional project teams.
- Master of Science Degree
- In depth experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- History of successful device submissions
- Strong negotiation skills and written/oral communication skills
- Strong organizational skills and time management skills
- Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
- Ability to work independently and under general direction only
- Computer skills; MS Office, MS Project, Adobe Acrobat and Agile
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.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
