Job Description Job Summary: The Senior Manager of Regulatory Affairs will provide guidance to RA Specialist & Clinical personnel regarding operational philosophy/procedures, manage RA Specialist & Clinical personnel hiring activities, manage training for RA Specialist & Clinical personnel, and cooperatively manage project allocations to facilitate timely completion while maintaining compliance with applicable national and international regulations. S/he will maintain current knowledge of applicable national and international regulations, act as consultant to other departments, participate in decision-making concerning policies, regulatory requirements and strategies, and manage external consultants as needed. S/he will define information and actions needed to meet requirements in a least burdensome manner, prepare documents and/or submissions required to obtain clearance or approval from governmental agencies for legal commercial distribution of products. The decisions made in this position have a very significant and substantial impact on the company. Determination of regulatory actions directly impacts Terumo’s ability to sell products. Interface with government agencies, regulatory groups, consultants and peers at other companies. Job Details: 1. Associate is responsible to follow requirements of applicable national and international regulations 2. Analyze, evaluate, verify, and organize information/data and writes/prepares documentation and submissions for the purpose of obtaining clearance/approval for legal market distribution of Terumo products. Participates on product design teams and verifies compliance with design control requirements and procedures 3. Oversee the direction, planning, execution, and interpretation of clinical trials/research and the data collection activities 4. Establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports 5. In coordination with the Clinical Project Manager, may recruit clinical investigators, negotiate study design and costs 6. Oversee the management of human clinical trials, phase I - IV for company products under development 7. Ensure that adverse event reporting and safety monitoring are conducted in accordance with the regulations 8. Monitor adherence to protocols and determines study completion 9. Oversee the coordination and development of data or information for reports submitted to the FDA and Global Regulatory Authorities 10. Communicates and works in conjunction with other internal and external entities to provide regulatory consultation and/or obtain information/data necessary for document preparation 11. Define projects and data/information required to meet the regulatory requirements for submissions, clinical evaluation and marketing/distribution of product 12. Actively participates on core project teams, in decision-making concerning departmental policies, determines regulatory requirements, clinical evaluation and strategies for legal distribution of medical products and in the selection of external consultants 13. Maintain current knowledge of applicable national and international regulations pertaining to legal distribution and clinical evaluation of medical products and provides training to internal and external persons. Must have knowledge of Clinical Research best practices and Good Clinical Practices (GCP) Regulations and relation Guidances 14. Management duties: Provides guidance/training to RA Specialist & Clinical personnel regarding operational philosophy/procedures, manage RA Specialist & Clinical personnel hiring activities, manage training of RA Specialist & Clinical personnel, cooperatively manage RA Specialist & Clinical allocations to project teams, manage individual projects, conduct meetings 15. Maintain documentation, reference databases, and historical records 16. Participate in industry task groups 17. Participate in project performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for unit/company performance improvement 18. Establish and promote a work environment amongst co-workers and direct reports that supports compliance with the TMC Quality System and Terumo’s policies 19. Perform other job related duties as assigned
Position Requirements: Knowledge, Skills and Abilities (KSAs) o Must have completed three (3) 510(k) submissions and, at least two (2) Pre-Market Approval submissions o Requires demonstrated ability to prepare submissions involving clinical trial support data and complete internal update documentation independently o Advanced ability for independent work, team work, and decision making o Must be capable to determine current regulatory requirements, define information/testing/data required to fulfill the requirements, communicating these requirements to others (TC/TMC/consultant entities), analysis to determine if information received is accurate and sufficient to fulfill requirements for PMA submissions.
understanding the design and execution of human clinical trials; assessing trial data with regards to product performance, patient safety and protocol compliance; managing multiple simultaneous projects o Regulatory Affairs and/or Clinical Research Associate Certification preferred Background Experiences o Bachelor’s degree in Science required o Minimum of 10 years experience in Regulatory / Clinical Affairs o Management experience required.