Manager, Regulatory Affairs

Cardinal Health Milpitas, CA
ESSENTIAL DUTIES AND RESPONSIBILITIES:

* Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.

* Instill and drive a regulatory culture. Establish and support policies and procedures for new products and sustaining ('base business' products.

* Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals/ maintain registrations to market products manufactured and/ or distributed by Cordis Corporation and/ or its parent company, Cardinal Health under the Cordis brand.

* Within the US, develop IDE/ 510K/ and PMA submissions for Class II and III medical devices.

* Within the EU, develop Technical Files/ and Design Dossiers for Class IIa/ b and III medical devices.

* Within the international markets, work with Cordis Regulatory affiliates to develop regulatory submissions for medical devices.

* Conduct submission negotiations with worldwide governmental regulatory agencies, as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.

* Maintain proficiency on regulatory requirements; develop and maintain rapport with worldwide governmental regulatory agencies reviewers, project team members.

* Provide continuing regulatory education and dissemination of regulatory information to the broader Cordis organization.

* Carry 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.

* Responsible for providing coaching and assistance to subordinates to ensure their development.

* Responsible for ensuring that 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.

* Works with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.

* Assist in the identification and management of departmental project and personnel issues. Responsible for communicating business related issues or opportunities to next management level.

* Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedure.

* Performs other duties assigned as needed.

* Responsible for communicating business related issues or opportunities to next management level

* For employees with supervisory responsibilities, ensure that 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

* Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets

* Performs other duties assigned as needed

EDUCATION/TRAINING and/or EXPERIENCE:

* Bachelor's Degree in Engineering, Physical or Biological science or related field of study, MS degree preferred.

* Five (5) to seven (8) years experience in the medical device industry with at least five (5) years in Regulatory Affairs.

* 3 years of direct supervisory experience.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:

* Proven expertise in all aspects of Regulatory Affairs, submission preparation, worldwide Medical Device law/ regulations, worldwide regulatory requirements/ procedures, project management and negotiations.

* Good working relationship with worldwide governmental regulatory agencies, with specific examples of experiences with FDA and EU Notified Bodies.

* International regulatory experience desired.

* Experience or transferable knowledge in the cardiovascular/ cardiology field preferred.