Medical Device, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
Job / Position Title
MANAGER, REGULATORY AFFAIRS
Functional Área / Department
Supervisor Job Title
Director of Cordis Global Regulatory affairs
SUMMARY OF THE JOB:Summarize the overall purpose of the position.
Develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.
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
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.
ADDITIONAL POSITION REQUIREMENTSInclude whether or not position will be required to work in clean room, near or with heavy machinery, ability to lift heavy objects, ability to wear protective gear in lab, etc
· Travel: 15%
· Occasional weekend/travel work may be required as necessary.
Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above statements are intended to describe the general nature and level of the work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
Internal Number: 1
About Cardinal Health
Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. The company provides clinically proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with approximately 50,000 employees in nearly 60 countries, Cardinal Health ranks #15 on the Fortune 500. For more information, visit cardinalhealth.com, follow @CardinalHealth on Twitter.