Director of Regulatory Affairs is responsible for developing and implementing regulatory strategies, submissions, and compliance activities, in support of global marketing of company products. The responsibilities are both managerial as well as "hands on" related to the preparation of regulatory documents. There will be extensive internal contacts within Lutonix and Bard Corporate Regulatory Affairs.
The position will report to the Vice President, Quality Assurance & Regulatory Affairs. There will be extensive external contacts with US and international regulatory authorities, physician advisors, and key industry specialists.
- Regulatory Programs: Will have primary responsibility for designing and managing effective regulatory strategies and submissions, encompassing the lifecycle of the company's products. Will provide regulatory guidance to ensure the company and its products comply with relevant national and international regulatory requirements.
- Timeline Preparation and Conformance: Working in collaboration with the VP, Regulatory/Quality Affairs, Corporate QRM and other departments prepare and manage regulatory submission and approval timelines consistent with companywide goals/objectives and insure that all necessary documents are submitted in a timely fashion to external organizations.
- Team Building: As needed, will be responsible for managing department staff and activities, and act as a core development team member, communicating regulatory requirements and strategies, and coordinating cross-functional team inputs support of the regulatory activities.
- Budget Management: Manage regulatory activities within annual budget for the Regulatory department.
- External Interactions: Interact frequently and maintain good relations with national regulatory agencies (FDA etc) in the US and abroad.
- Regulatory Strategy: Develop and implement regulatory strategies for a new Class Ill device through interface with FDA, International Regulatory Agencies, physicians, consultants, and internal team members.
- Regulatory Approvals: In conjunction with R&D, Quality, Pre-Clinical and Clinical, prepare or direct the generation of applications for conducting clinical investigations and product approvals in U.S. and OUS.
- Regulatory Compliance: Ensure compliance with relevant FDA and International regulations and guidelines, including MOD, 51O (k), IDE, PMM, GMP, MDR/Vigilance reporting, and labeling/advertising.
- Regulatory Procedures: Ensure compliance with departmental and corporate regulatory affairs policies and procedures