Sr. Regulatory Affairs Specialist

JOB TYPE: Full Time, Employee JOB CATEGORY: Quality Assurance/Safety CITY: Redmond STATE: WAAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Sr. Regulatory Affairs Specialist Position Description Responsible for determining and advising management of FDA compliance requirements including evaluation of corporate compliance. Prepared regulatory submissions. Decisions affect the timing of product introductions and company standing with FDA compliance. Position Responsibilities 1. Research new FDA decisions or rulings and how they may affect the company's activities. 2. Prepare and submit new product FDA applications. 3. Maintain relationships with the FDA in order to obtain approval for regulated products. 4. Monitor operating activities and advise management on relevant current or pending decisions. 5. Review/comment/approve product labeling. 6. Maintain corporate FDA registration and listing. 7. Support FDA inspection activities, and maintain records. 8. Conduct corporate training in GMP and other regulations. 9. Conduct various internal compliance audits. 10. Perform other related duties as assigned. Basic Qualifications * Bachelor’s degree in engineering, biological sciences or allied health care, or equivalent and minimum 5 years' directly related experience. Desired/Preferred Qualifications * Strong analytical skills required with the ability to analyze technical requirements and regulations which apply to the corporation. * International regulatory submission experience highly preferred. * Good organizational, interpersonal and communication skills. Physical Job Requirements Normal fast-paced office environment, with significant use of computer keyboard, monitor, and mouse. Minimal travel may be required. Visit and apply at www.medtronic.com, use requisition #: 59792   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an equal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/careers   Click here to see other Medtronic opportunities  Email this Job to a Friend