Responsible for the review and evaluation of all FDA submissions to assure accuracy and completeness of submission documents for IDE/PMA/510k products.
Determines submission requirements and requests needed data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate.
Reviews and provides signatory approval for reports and amendments to IDEs/PMAs, assuring submission within specified regulatory timeframes. Reviews and approves for accuracy and completeness all materials to be included in submissions, including materials prepared by others and supplied to Regulatory.
Responsible for routine correspondence with FDA regarding investigational and marketed products and liaison with FDA reviewing divisions for assigned products, applications, and reports.
Plays role in determining filing strategies.
Interacts with all departments, facilities, and affiliates with regard to investigational and marketed products for required information and documentation.
Responsible for regulatory guidance regarding investigational and marketed products (U.S.).
Advises Regulatory Management of any delays in submissions or potential regulatory problems for investigational and marketed products (U.S.).
Performs other projects, project-based tasks and/or special projects as assigned by Regulatory Management.
Other job responsibilities as needed.
Supervise direct reports: Yes
Key Relationships: Research and Development, Manufacturing, Legal, Quality, Clinical Affairs, Marketing, US FDA, EU Notified Bodies, Sales, Customer Service
Requires excellent verbal and written communication skills for interaction with all levels of personnel in the corporation. Must have good analytical reasoning, must be detail and solutions oriented and must be able to work in a team environment. Must have ability to develop, articulate, and adequately explain decisions, opinions, and recommendations in implementing and interpreting, implementing and applying complex regulatory rules, regulations, guidances, and instructions to company devices and projects.
Requires moderate to high level competencies in operation and manipulation of PC-based office equipment and related database and word processing software.
Must maintain competence in current regulatory device issues and requirements by vigilance in reviewing available printed and electronic literature, and by attending professional seminars, workshops, classes, and meetings as appropriate.
B.S. degree in health related sciences or pharmacy degree required; MS degree a plu. Seven years regulatory affairs experience, with a minimum four years direct FDA device submissions experience (IDE/PMA/510k) required. Experience in Devices and Device Regulations a must.
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