Sr Regulatory Affairs Spec

Medtronic. Careers with a passion for life.As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. Everything we do is deeply rooted in our mission—to alleviate pain, restore health, and extend life. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for seven of the last nine years by Fortune magazine as one of the "100 Best Companies to Work For in America." Work with the kind of people who not only love what they do but why they do it.
Sr Regulatory Affairs Spec
Minneapolis, MinnesotaThe Senior Regulatory Affairs Specialist develops strategies for worldwide governmental approval to introduce new products to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The incumbent also assists with the training of less senior regulatory affairs personnel and provides work direction on projects of large scale.
Responsibilities: •Prepare worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory issues with manager/director, as necessary, and negotiate submission issues with agency personnel.•Prepare regulatory strategies/plans and worldwide requirements lists. Provide on-going support to product development teams for regulatory issues and questions.•Provide business and product information to international regulatory manager to enable development of strategies and requirements, and communicate that information to business teams. Provide product and test information to support international submissions.•Provide support to currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.•Negotiate directly with the FDA on all projects/products. All significant issues will be reviewed with the manager/director.•Develop general strategies on how to interact more effectively with government agencies and agency personnel.•Provide training and support to newer members of the department.•Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
REQUIREMENTS
KNOWLEDGE/EDUCATION:
•Bachelor’s Degree
Preferred:
Degree in Engineering, Physical/Biological SciencesJOB EXPERIENCE:
•6-10 years industry experience
•3-5 years regulatory experience with Class III Devices
Preferred:
•Regulated clinical experienceSKILLS/COMPETENCIES:
•Demonstrated proficiency with regulatory planning/strategy (510(k)/IDE/PMA submission planning/preparation)
•Negotiation skills
•Knowledge of Medtronic product design /manufacturing/development systems
•Proficiency in worldwide regulatory requirements and procedures
•Submissions related WP skillsPHYSICAL REQUIREMENTS:
None
We are currently seeking multiple individuals for Regulatory Affairs & QA opportunities throughout Medtronic. Qualified candidates with all levels of experience are encouraged to submit an application in consideration for this or similar opportunities. This opportunity is based in Minneapolis, Minnesota. Other opportunities may also exist at our locations in Northridge, California; Santa Rosa, California; Redmond, Washington; Denver (Louisville), Colorado; Ft. Worth, Texas; Memphis, Tennessee; Danvers, Massachusetts; and Jacksonville, Florida.With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.
TO APPLY: Please submit your resume at www.medtronic.com/employment. Review Regulatory Affairs openings or enter Requisition # 52238 and select "Add to Cart" or "Apply to this Job" 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.