Regulatory Affairs Manager

Regulatory Affairs Manager St. Jude Medical, Atrial Fibrillation Division is committed to reducing the effect atrial fibrillation has on its patients!  Atrial fibrillation (AF or A Fib) is the most common abnormal heart rhythm.  It is a very fast, uncontrolled heart rhythm that occurs when the upper chambers of the heart try to beat so fast that they can only quiver.  We are seeking exceptional candidates to fill the following position in our Minnetonka, MN location:  Regulatory Affairs Manager Responsible for planning, creating and implementing solutions for global approvals of Division products. Develops experience-based regulatory strategies for products used in existing medical procedures, and recommends viable strategies for unique product introductions. Negotiates regulatory submission and product approvals with regulatory agencies around the world directly and through distributors. Participates in industry regulatory focus groups.  Manages the regulatory staff to support and develops junior regulatory staff. Activities may include submissions of PMA, PMA(S), CE Design Dossiers and Technical files, 510(k) and IDE, and other types of regulatory documents.  Supports product development teams by assigning and managing regulatory staff and resources to support the product development process. Advises and trains departments and individuals regarding latest regulatory developments and trends.  Reviews and approves reports and document change orders, advertising and promotional materials, and other internal documents for regulatory compliance.  Responsibilities Manage regulatory staff and department activities to effectively support the AF Division business objectives and compliance requirements. Manage staff to support worldwide regulatory submissions and approvals.  Manage staff development and career goals FDA related activities and oversight International related activities and oversight Facilitate the implementation of management directives within the regulatory department. Qualifications  BS in Engineering or Sciences.  Must have at least 10 years of industry experience including 5 years of regulatory experience within the medical device industry or related medical feild.  Must have the proven ability to bring a variety of projects to successful completion.  Must have current knowledge base on existing and emerging regulations, standards, and guidance documents.   Preferred Qualifications Successful track record of novel FDA and multiple country approvals.  Master degree in Life Sciences or Business.  Regulatory Affairs Professional Certification.  Member of an industry working group.   Qualified candidates may apply online via our website via our website at www.sjm.com and reference position AF11750.  Apply Now! St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.