Senior Regulatory Affairs Specialist - Mechanical Circulatory Support (hybrid) at Medtronic in Miami Lakes, Florida

Job Description:

Senior Regulatory Affairs Specialist - Mechanical Circulatory Support (hybrid)

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 (Sr. RAS) develops and executes strategies for global regulatory approvals working with Medtronic Geography Regulatory partners, and global regulatory agencies to introduce Mechanical Circulatory Support (MCS) product changes to market. The Sr. RAS provides advice on regulatory requirements, prepares submissions and negotiates their approval. The Sr. RAS also assists with the license maintenance including annual reports, renewals, design/manufacturing change notification, QMS audit, and Manufacturing site registrations.

The preferred location for this role is Miami Lakes, FL or Minneapolis, MN.

A Day In The Life

• Responsible for coordinating the planning, preparation, assembly, and review of regulatory submissions to the FDA, Notified Bodies and other worldwide government agencies as required to ensure timely approval for market release. Able to write regulatory justifications to support submission filing decisions.
• 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.
• 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. This includes reviewing labeling and changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required. Find, interpret and apply regulations and guidance appropriately for situations.
• 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 Mechanical Circulatory Support (MCS) 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.
• Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
• 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 experience in regulatory affairs in the medical device industry with Bachelor's degree
• Minimum 2 years of experience in regulatory affairs, in the medical device industry with Master's degree

Nice To Have

• Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and working with cross-functional project teams.
• 4+ years medical device industry experience
• In depth experience with FDA requirements, guidance documents, Active Medical Device Directive, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Experience with Class III medical devices (PMA)
• EU MDR strategy and implementation
• History of successful device submissions and PMA Supplements
• Experience performing advertising and promotion reviews for medical devices
• 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

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.