St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minnesota, St. Jude Medical employs approximately 14,000 people worldwide and has five major focus areas that include: atrial fibrillation, cardiac rhythm management, cardiac surgery, cardiology and neuromodulation.

With projected revenue to be over $1 Billion by 2012, our fastest growing division, Atrial Fibrillation Division (AFD), is committed to by hiring world class talent that will continue to drive us to lead the way in the treatment and cure for atrial fibrillation. St. Jude Medical is the only medical device company to dedicate a business unit solely to diagnosing, treating and curing atrial fibrillation, the world\'s most common cardiac arrhythmia.

Senior Manager, Regulatory Affairs

We are seeking a high caliber leader for this Senior Manager of Regulatory Affairs position to manage the AF Divisions regulatory department supporting our Minnetonka manufactured catheter based product line. This is a hands-on Senior Manager role supporting worldwide submissions and existing marketed products within the company’s portfolio. This role will develop and implement regulatory strategy/tactics, and develop a team of regulatory professionals.

Impact this role will have:
• Manage and assign staff resources and support of project teams, mfg, continuation engineering, and post market regulatory maintenance activities.
• Provide appropriate level of technical guidance, training and mentoring to staff, during strategy formulation, submission preparation and in the development of labeling, marketing or promotional materials.
• Liaison and manage the relationship with FDA and global Regulatory authorities to professionally represent the company, its interests and foster a collaborative relationship on regulatory issues.
• Recruit, hire, train, and retain high performance regulatory team
• Manage regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
• Ensure that regulatory submissions and design documentation meet standards with respect to technical excellence,
• Collaborate with other departments on the quality and content of regulatory documentation and reports
• Lead and/or participate in department and divisional operational efficiency initiatives.
• Establish a leadership position on project development teams on behalf of the regulatory staff and ensure appropriate communication within RA and across other functional areas to meet team objectives;
• Identify risk areas and develop alternative courses of action including anticipation of Regulators responses through scenario planning and development of contingency plans;
• Monitor applicable regulatory requirements; assure compliance with company and external standards;

Required Qualifications
• Bachelor’s degree (BS, BA) in technical field
• Minimum ten (10) years technical and Regulatory Affairs experience in the Medical Device Industry
• Minimum of five years of management experience
• Thorough knowledge and understanding of US and International Medical Device Regulations
• Proven project management skills- analytical and highly developed problem solving skills
• Ability to define problems, collect data, establish facts and draw valid conclusions and present to management.
• Motivating leadership and coaching skills
• Strong written and oral communication and negotiations skills

Preferred Qualifications
• Master’s degree (MS, MA, MBA) preferred.
• Regulatory Affairs Certification (RAC) preferred.
To learn more, visit our web site at www.sjm.com.
St. Jude Medical is an equal opportunity employer.

To learn more and to apply for this position visit our web site at www.sjm.com. Reference position #AF11973.

St. Jude Medical is an equal opportunity employer.

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