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.
Provide regulatory guidance to Marketing and the management team on requirements related to advertising, promotion, labeling, corporate and public communications and materials.
Manage supplier and distributor qualifications and the organization’s internal and external auditing program.
Work with multidisciplinary teams on the commercialization to ensure compliance with FDA regulations including:
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).
CMC development and implementation
Support of clinical trial protocol development
Oversee and maintain licensing, registration, and accreditation with the different state, federal, and independent regulatory bodies.
Support and maintain regulatory reporting endeavors including but not limited to MedWatch, Clinicaltrails.gov and Biological Product Deviations.
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.
Performs other related duties as assigned.
Experience: Minimum of 7 years Tissue Bank, Medical Device, Biologics or Pharmaceutical experience with 4 years management experience preferred.
Licenses/Certifications: AATB CTBS, ASQ, or other allied health licensure or certification preferred.
Internal Number: RA001
About Vivex Biomedical
Vivex strives to create treatment options and solutions that will improve clinical, surgical, and therapeutic patient care through innovation. Under the guidance of experienced and successful business professionals, Vivex tasks the brightest minds from the medical and material science industries to explore new and different ways to help others. Vivex works with services that are committed to providing care and compassion to donor families while inspiring communities to share life through their donation. Partnering with families in the prospect of regenerative options, Vivex assures appropriate options are available to support regeneration and translation of their gifts.