Regulatory Affairs Director

Medtronic   •  

Northridge, CA

Industry: Manufacturing


11 - 15 years

Posted 36 days ago

Regulatory Affairs Director
Careers That Change Lives We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Join our team in Regulatory Affairs, and help shape policies that change lives.
Bring your leadership expertise to our Diabetes Group Regulatory Affairs organization and implement policies, procedures, practices, and strategy. Great exposure and interaction with members and executives from U.S. and international regulatory officials. The Diabetes Group is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes, so people with diabetes can enjoy greater freedom and better health.We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Click here to see an overview of the products in our Diabetes product portfolio.

* A Day in the Life You will manage domestic and international regulatory submission activities for Medtronic Diabetes products. * You will develop and implement regulatory submission strategies that result in the shortest possible regulatory approval cycles for new products while maintaining full compliance with all applicable laws and regulations. * You will direct the activities of Regulatory Submission Specialists in preparing high quality regulatory approval applications. Submissions to the U.S. FDA will include 510(k), IDE and PMA submissions.* You will partner with cross-functional team members such as engineers, clinical, marketing, quality and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

Minimum Requirements
• Bachelors degree required• Minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience

Nice to Have
• Experience in the medical device industry• Experience interacting with FDA and/or other regulatory agencies (e.g. to identify information required to obtain product approval and to resolve areas of disagreement)Master’s Degree or Doctorate in Regulatory Affairs and Regulatory Affairs Certification (RAC) would be ideal.• Experience in regulatory submissions for Diabetes-related medical devices highly preferred.• Thorough knowledge of medical device product development and design control.• Previous involvement in presentations to FDA Advisory Panels.• Knowledge of FDA policies as well as familiarity with current FDA requirements and expectations

About MedtronicTogether, 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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
Ability to travel up to 25%
EEO 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.