KEY TASKS
- Ensure compliance with Cardinal Health policies and procedures and to the Quality Management System.
- Develop submissions for Class II, III and IV medical devices for local regulatory body
- Conduct submission negotiations with the local regulatory body as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval
- Maintain proficiency on regulatory requirements and develop and maintain rapport with local regulatory body reviewers, project team members
- Assess product changes for impact to registrations and maintain registrations with the global regulatory system.
- Manage documentation of the Quality Management System
- Ensure regulatory compliance for Medical Devices (MDs): access to the market, distribution of the products, life cycle management, declare to national competent authorities
- Review and approve translations of product labeling (e.g., labels, IFU, user manual) and promotional material (external and internal communication)
- Ensure regulatory and quality training and assessments for marketing departments, medical devices representatives and other concerned employees
- Contribute to Regulatory intelligence (involvement on internal and external working group, participation to meetings and congresses) and monitoring of new and changing regulations.
- Manage the complaint handling process including vigilance reporting to authorities.
- Coordinate MDs Field remedial actions, recalls and communicate with local authority and customers.
- Ensure compliance with national regulations and regulating agencies and other international bodies. Interpret the intent of regulations and policies and provide such information to project teams and management
- Instill and drive a regulatory and quality culture within the region.
- Support internal and external audits and inspections as applicable
- Coordinate corrective and preventive actions
- Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups globally to support education of local regulations
- Lead a team of regulatory and quality professionals and ensure 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
- Assist the marketing/sales group in the tendering/bidding process
KEY COMPETENCIES
- Consistent background and knowledge of MD regulations
- Relations established with the key interlocutors in the network of the MDs (e.g., regulatory agencies such as ANSM, professional organizations, etc.)
- Ability to identify early the risks incurred by the company, to make the necessary warnings and propose appropriate action plans, in agreement with the Quality Assurance and Regulatory Affairs Director
- Ability to work in team and to share experiences
KEY REQUIREMENTS (DEGREE, EXPERIENCE, ETC.)
- Bachelor’s Degree in Science or related field of study;
- 8 + years industry experience in the industry. Medical device experience required. 2-5 years leadership experience required..
- International regulatory and quality experience an asset
- Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, local regulatory body Device Law/Regulations, Global Regulatory Requirements/Procedures, Project Management, and Negotiations
- Bilingual English/Korean
- Travel: 15%
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.
Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.
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