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Senior Manager -Regulatory Affairs

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Regulatory Affairs
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20000JL0 Requisition #

SENIOR MANAGER - REGULATORY AFFAIRS 

The Cardiac Ablation Solutions (CAS) division is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care pathway, cardiac mapping and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, to date CAS has transformed the lives of almost 1 million patients.

Careers that Change Lives

As Senior Manager, Regulatory Affairs in the Cardiac Ablation Solutions operating unit you will provide direction and leadership to Regulatory Affairs Specialists within the CAS operating unit in the development and implementation of global regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. Provide management support to submissions, regulatory activities, clerical staff, and supervise the preparation of deliverables to introduce new/ changed products to global markets.

A Day In The Life

  • Work with direct reports to develop successful regulatory strategies to ensure timely device approvals. 
  • Lead negotiations with regulatory agencies. 
  • Able to take on complex issues and tenaciously execute plan regardless of obstacles. 
  • Provide management and leadership to the Regulatory Affairs organization in such areas as personnel, objectives, projects and responsibilities. Contribute to the development and implementation of business unit strategic and operating plan 
  • Provide work direction, training and regulatory advice to direct reports and other members of the regulatory department. Interview and hire staff as necessary. Review personnel decisions to ensure harmony with overall department goals. 
  • Review submissions of less experienced regulatory staff and coach as necessary to ensure continuing development of regulatory skills. 
  • Keep Senior Management informed of regulatory status of products and significant regulatory issues, and update them about new developments. 
  • Maintain proficiency on regulatory requirements and develop and maintain rapport with regulatory bodies, group leaders and ancillary personnel. 
  • Conduct annual performance reviews. Assist with setting of objectives and professional development of staff. 
  • Provide continuing regulatory education and dissemination of regulatory information to the development, marketing and clinical groups. 

Must Have, Minimum Requirements

  • Bachelor’s Degree (No equivalencies)
  • Minimum 7 years experience in Regulatory Affairs for a medical device company or advanced degree with a minimum of 5 years of relevant experience in Regulatory Affairs for a medical device company
  • Minimum 5 years experience as a Manager.

Nice To Have

  • Medical or technical degree preferred
  • Five or more years project / personnel management experience, preferable in regulatory/quality system environment.
  • Experience at formulating successful regulatory strategies that meet aggressive preparation and approval timelines, while maintaining the highest level of quality 
  • Highly motivated and results-oriented leader 
  • Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, All Phases of FDA Device Law/Regulations, WW Regulatory Requirements/Procedures, Project Management, Negotiations, Medtronic Product/Design/ Development Systems 
  • Proficiency in FDA compliance
  • Submission related word processing 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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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.
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