Director, Regulatory Affairs

The Director of Regulatory Affairs will be responsible for the coordination, compilation and submission of biologics and medical device applications in addition to other various submissions to regulatory agencies. This person will be responsible for supporting and guiding the developing and implementing Chemical and Manufacturing Controls (CMC). This role will also provide guidance to project teams on the current regulatory framework from the Food and Drug Administration (FDA) to ensure the added value to the business from the commercialization of medical products. The Director of Regulatory Affairs will be responsible for managing supplier and distributor qualifications and the company’s auditing program as well as maintaining voluntary accreditations, state licenses and establishment registrations and listings.

Responsibilities

1. Provide regulatory guidance to Marketing and the management team on requirements related to advertising, promotion, labeling, corporate and public communications and materials.
2. Manage supplier and distributor qualifications and the organization’s internal and external auditing program.
3. Work with multidisciplinary teams on the commercialization to ensure compliance with FDA regulations including:
   1. Coordination, compilation, and submission of regulatory filings including but not limited to: Requests for Designation (RFD), Investigational New Drug (IND), Biologics License Application (BLA), 510(k), and Pre-Market Approval (PMA).
   2. CMC development and implementation
   3. Support of clinical trial protocol development
4. Oversee and maintain licensing, registration, and accreditation with the different state, federal, and independent regulatory bodies.
5. Support and maintain regulatory reporting endeavors including but not limited to MedWatch, Clinicaltrails.gov and Biological Product Deviations.
6. Remains current in industry trends and practices up to and including association memberships with committee or work group participation. Identifies patterns to improve processes. Assists in the development and improvement of policies and procedures for all aspects of business, to include data collection and regulatory compliance.
7. Performs other related duties as assigned.