Senior Director of Regulatory

1. Manage all aspects of all ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and international (e.g., CE Technical Files, Design Dossiers, APAC, etc.). Provide regular status updates and activity reports to Company management, including budget aspects.
2. Through the regulatory team, provide strategic direction and advice to project and Company management regarding regulatory pathways and timelines for new and changed products/processes.
3. Establish, organize and maintain regulatory records.
4. Act as company liaison with FDA and other regulatory agencies.
5. Monitor and ensure appropriate ongoing Company-wide regulatory compliance with applicable GMP/ISO/EN standards and other pertinent standards. Review and assist in the development of Company Quality Manual and standards.
6. Obtain and manage foreign registrations; partner with appropriate representatives to locally confirm and file foreign regulatory requirements.
7. Organize and plan regulatory activities in line with company's business priorities, including budget.
8. Establish SMART goals for the regulatory team and conduct regular performance reviews for all team members to ensure achievement of goals. Establish and support development plans for all team members.
9. Prepare and manage department budget.
10. Maintain familiarity with current medical literature and surgical techniques in the field of ophthalmology.
11. Other duties as assigned.
B.A. /B.S. degree required.
Advanced degree or MBA preferred.
Minimum of 5 years of hands-on experience in Regulatory Affairs in the medical device or pharmaceutical industry required.
Experience in intraocular lens or vision care industry preferred.
Must have extensive experience preparing all types of FDA/ISO/CE submissions and documentation.
Experience managing clinical studies preferred.
Experience interacting with domestic and international healthcare professionals and company management required.
Strong statistical and analytical skills.
Working knowledge of PC-based word processing, spreadsheet, and relational database software required.
Excellent written and oral communication, and technical writing and editing skills.
Ability to manage and prioritize multiple projects and organize departmental resources to meet business objectives.

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