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Principal Regulatory Affairs Specialist

Regulatory Affairs
1700072U Requisition #
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The Principal Regulatory Affairs Specialist demonstrates quality in all actions; works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.  Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.  Networks with key contacts outside own area of expertise.  Participates in cross-functional team meetings. Consults with regulatory manager or director to establish and prepare appropriate regulatory filings for product approvals and provide regulatory guidance and support. Maintains current knowledge of FDA, European and Worldwide Regulatory Authority programs, policies and other critical regulatory information. Assists in the development and execution of effective regulatory affairs strategies with team representatives and with the Manager or Director of Regulatory Affairs.


Essential Duties And Responsibilities
Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.   Coordinates activities concerned with the submission and approval of medical device products to government  regulatory agencies by performing the following duties:
• Assists in the development of worldwide regulatory strategies and filings for product approvals.
• Provide regulatory support to cross-functional project teams in conjunction with direct manager.
• On a project team, makes decisions involving worldwide submissions and provides advice and counsel to other team members with the assistance of direct manager.
• Assist and/or prepare and submit FDA submissions (e.g., IDEs, PMAs, HDEs, Progress reports, UADEs, device listing)
• Assist and/or prepare dossiers for submission to worldwide regulatory agencies (e.g., Latin America, Asia Pacific).
• Reviews and approves change requests and Change Orders.
• Maintains current knowledge of FDA, European and Worldwide Regulatory Authority programs, policies and guidelines.
• Assures that all submission documentation, record keeping and reporting meet inspection standards as established by regulatory agencies worldwide.
• Assist in the process for the development and release of labeling materials (Instructions for Use and patient materials) intended for users of HeartWare products. Assist in coordinating and executing all activities necessary
including proofreading, translation management, and release of labeling. Ensures all labeling materials are designed in accordance with company and regulatory standards. Maintains current and in-depth knowledge of FDA, European and Worldwide medical device regulations related to labeling


• 8 years of experience, preferably in the medical device industry or related field experience (e.g., hospital / clinical setting, laboratory setting)
Required Education/ Experience (Describe the minimum education/experience required to perform the position)


Preferred Skills
• Information Mapping

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.
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.

Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology 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 can 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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status or any other characteristic protected by federal, state or local law.  In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:  http://www.uscis.gov/e-verify/employees
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


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