HireDiversity

Fremont, CA, US

Program Director, Regulatory Affairs-1431121128

Description

Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is recruiting for a Program Director, Regulatory Affairs, to be located in Fremont, California.

Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.

Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.

The Program Director, Regulatory Affairs develops and implements regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards. Ensures compliance with global regulations and regulating agencies. Interprets the intent of regulations and policies and provides such information to project teams and management. Instills and drives a regulatory culture. Establishes and supports policies and standards for new products.

The Program Director, Regulatory Affairs develops and executes worldwide strategies for product registration, notification, or pre-market approval requirements. Partners with WW Clinical Operations to develop clinical strategies and ensures compliance with local, state, and Federal regulations for conducting clinical trials worldwide. Manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by Cordis and/or J&J affiliates. Directly or through subordinate staff, develops US IDE/510K/ and PMA submissions for class II and III medical devices, and EU Design Dossiers and Technical Files. Directly or through subordinate staff, generates documentation to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by Cordis and/or J&J affiliates.

The Program Director, Regulatory Affairs conducts submission negotiations with the FDA as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval. Maintains proficiency on regulatory requirements; develops and maintains rapport with FDA reviewers, project team members, and other stakeholders. Provides continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

This individual works with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups. Responsible for providing performance feedback to direct reports as well as coaching and assistance in their development. Identifies and manages departmental project and personnel issues. Responsible for communicating business related issues or opportunities to next management level. Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Performs other duties assigned as needed.

Qualifications


A Bachelor's degree in Engineering, Physical or Biological science or a related field of study and a minimum of 10 years or relevant regulatory affairs experience OR a Master's degree and a minimum of 8 years of relevant regulatory affairs experience is required. Medical Device industry experience is required. A minimum of 3 years of direct supervisory experience, including management of direct reports as well as external consultants is required.

Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, FDA Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations is required. A good working relationship with the FDA, including direct experience with face-to-face meetings and direct negotiations with the FDA is required. International clinical and regulatory experience is required. Direct experience in obtaining FDA approval/clearance of PMAs, 510(k)s, and IDEs is required. Cardiovascular device experience is desirable. Excellent written and oral English communication skills are required. The ability to use PC's and associated software is required.

Up to approximately 10% domestic and international travel may be required. This position will be located in Fremont, California.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-California-Fremont
Organization: Cordis Corporation (6017)