Position Title
Regulatory Affairs Director
SBU
Corporate
Department
Regulatory Affairs
Relocation Covered
YES
Educational Requirements
Bachelor's degree
Experience Requirements
Manage all aspects of regulatory affairs with focus on products regulated by the US Food and Drug Administration. Responsible for regulatory strategies, submissions, and for managing interactions with the regulatory agencies. Responsible for ongoing management and development of staff. Ensure that regulatory positions are staffed with qualified, motivated employees. Ensure that reports are appropriately trained, and have the resources necessary to do their assigned jobs. Provide reports with career development opportunity, and help them to realize their career goals. Provide regulatory support to ensure that strategies for the registration of products are appropriately registered in the U.S. Stay abreast of evolving global regulatory requirements.
Qualification Requirements
Strong regulatory and quality systems knowledge. Supervisory / management skills. Strong problem solving skills. Computer literate (word processing, spreadsheets, databases). Documentation skills, negotiating skills and the ability to communicate effectively. Research, logic and technical writing skills. Presentation / training skills. Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts.
Preferred Qualifications
B.S. degree or the equivalent with 8 or more years of relevant experience. Broad regulatory knowledge base including global requirements for: marketing approvals; change assessment; complaint handling; adverse event reports; recalls; Advertising and promotional labeling; and quality systems. Regulatory certifications preferred, e.g., RAC, CQA, CQE, CQM. Experience working with FDA relative to premarket and compliance activities. Experience with 51O(k)s, IDE’s, technical files, and Canadian device licenses.
Responsibilities
Primary accountability for key submissions including 510(k) and IDE. Manage direct reports in multiple sites. Responsible for determining the impact of scientific and technical information on submissions. Ensure compliance with product development and design control procedures during development activities. Work directly with regulatory agencies to promote agreement on filing strategies or resolve problems. Guides, directs and coordinates regulatory function as it impacts other functional areas. Interacts with others to ensure implementation of regulatory strategies. Accountable for overall policies relative to advertising and promotional labeling review and approval. Ensure compliance to these policies. Ensure compliance to corporate compliance systems. Analyze world wide regulatory requirements for new or significantly changed products and author any necessary marketing approvals. Ensure compliance training of new employees and transferees.
