Regulatory Affairs Manager - 32413

for cardiac rhythm management, vascular intervention and cardiac/vascular surgery worldwide. Our mission is to provide innovative, therapeutic medical solutions of distinctive value for our customers, patients and health care systems around the world. In our industry, we have always been known for leadership and innovation, and for an organizational structure that allows employees freedom to grow.

 

Regulatory Affairs Manager

Santa Clara, CA

VI/I-MB/32413

 

The manager of Regulatory Affairs is responsible for the management and leadership of the Regulatory Affairs department. The manager is responsible for allocating and managing department resources to accomplish department and corporate objectives.

 

Recruits, coaches and develops organizational talent.

Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.

Creates an entrepreneurial environment.

Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.

Keeps the organization's vision and values at the forefront of decision making and action.

Demonstrates effective change leadership.

Builds strategic partnerships to further departmental and organizational objectives.

Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.

Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).

Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.

Develops, monitors and appropriately adjusts the annual budget for department(s).

Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.

Assess proposed regulations and communicate new requirements to the organization.

 

Position Qualifications Bachelor's degree and 9+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.

Additional Responsibilities Unique to this Position:1. Guide and educate the teams and regulatory personnel regarding current requirements for combination products and new therapies.2. Participate in cross-functional efforts to ensure best practicies for regulatory affairs. Additional Qualifications Required:1. Regulatory experience in combination products; preparation of PMA, PMA/S, IDE, NDA, or IND.2. Excellent writing, team building and organizational skills.3. Experience with regulatory agency interactions. Additional Qualifications Preferred:1. Knowledge of product development (device, combination products and/or drug)2. Experience with approval strategies for novel therapies.3. International regulatory experience.

Posting ID 19935BR

 

Guidant offers a company environment of market leadership, product innovation and personal growth, plus excellent benefits, including medical, dental, vision and life insurance, short and long-term disability, paid vacations and holidays, 401(k), retirement ESOP, annual bonus, paid year-end shut down, and tuition reimbursement.

 

For further details about this position and to apply, please visit: https://sjobs.brassring.com/1033/ASP/TG/cim_jobdetail.asp?partnerid=95&siteid=5184&AReq=19935BR&Codes=I-MB

 

Guidant is an Equal Opportunity Employer and maintains an Affirmative Action Program.