Manager Of Regulatory Affairs Jobs in Minnesota

Job Title: Regulatory Affairs Manager Company: Medtronic Location: Minneapolis, MN Description: Medtronic Job Details Regulatory Affairs Manager Requisition 71379 Category Regulatory Affairs and QA Business Cardiac Rhythm Disease Mgmt Division CRDM Regulatory Affairs Location USA-MN-Mpls-Mounds View Relocation Relocation eligibility to be determined Job Type Full Time - Regular Exempt/Non-Exempt Exempt Shift First Travel Percentage 10 - 20% Experience Required 5 years Education Required Bachelors Degree Medtronic is an Equal Opportunity/Affirmative Action Employer Position Description Provide direction and leadership to Regulatory Affairs Managers and Specialists in the development and implementation of regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.  Provide management support to submissions and clerical staff. Position Responsibilities •  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. •  Direct submission negotiations with FDA as needed (depending on level of experience of Regulatory Affairs Specialist), including pre-submission identification of requirements and strategy and post-submission negotiations to ensure timely approval. •  Maintain proficiency on regulatory requirements and develop and maintain rapport with FDA reviewers, group leaders and ancillary personnel.   •  Ensure the support by regulatory staff of the international regulatory managers. •  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. •  Oversee a portion of the department budget; approve spending within defined limits. Basic Qualifications KNOWLEDGE/EDUCATION *  Bachelor’s Degree JOB EXPERIENCE •  At least 5 years of industry experience •  At least 4 years Regulatory experience with Class III Devices •  At least 4 years of combination device / pharmaceutical experience •  Extensive experience at formulating successful regulatory strategies that meet aggressive preparation and approval timelines, while maintaining the highest level of quality Desired/Preferred Qualifications *  Degree in Engineering, Physical/Biological Sciences •  1-2 years in a management role or demonstrated supervisory and interpersonal skills •  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 •  Prior experience with leads development Physical Job Requirements •  Office environment – ability to use a keyboard, mouse, and visually interact with personal computers

Job Title: Regulatory Affairs Manager Company: Medtronic Location: Mounds View, MN Description: Employer Information About Medtronic Medtronic. Careers with a passion for life. As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. We also are dedicated to the total well- being of our employees and have been recognized as a Fortune “Best 100 Companies to Work For in America.” Work with the kind of people who not only love what they do but why they do it. View all our jobs Job Imagine playing a role in changing what it means to live with chronic disease. At Medtronic, you can. We're creating technologies that treat chronic disease in new ways so people can live better, longer. We didn't become a global leader by sitting on the sidelines. We're actively involved in shaping the industry and transforming technologies so physicians have what they need to help their patients move forward with life. Our vision requires bold leaders. If you want a career that is challenging, energizing, and rewarding, we hope you’ll consider joining us as we push the boundaries of medical technology. Position Provide direction and leadership to Regulatory Affairs Managers and Specialists in the development and implementation of regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. Provide management support to submissions and clerical staff. Position Responsibilities 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. Direct submission negotiations with FDA as needed (depending on level of experience of Regulatory Affairs Specialist), including pre-submission identification of requirements and strategy and post-submission negotiations to ensure timely approval. Maintain proficiency on regulatory requirements and develop and maintain rapport with FDA reviewers, group leaders and ancillary personnel. Ensure the support by regulatory staff of the international regulatory managers. 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. Oversee a portion of the department budget; approve spending within defined limits.