Senior Director of Regulatory Affairs, BioPharmaceutical

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Fort Worth, TX
$170,000 - $225,000
Job Type
Direct Hire
Master, Bachelor of Science
Oct 10, 2018
Job ID
The (Senior) Group Director, Regulatory Affairs has responsibility, as assigned, for two functional global areas: Wound Device products as well as Pharmaceuticals and Biologic products in the USA, EU and UK.  This is a unique opportunity to lead a global product category consisting of medical device and pharmaceutical products, existing and new product development with a revenue exceeding $350M and growing!

Must have experience working directly with UK and MHRA submissions and in-person meetings.

Senior Director of Regulatory Affairs Responsibilities:
  • Responsible for leading a regulatory team at two locations (Fort Worth, TX and Hull, UK)
  • Responsible for submission of all product submissions including Class III medical device, 510(k)'s and Pre-market Approval Applications PMAs; BLAs, INDs. Responsible for the review of technical dossiers and essential requirements checklists for CE marking of products.
  • Responsible for assuring compliance with all medical device laws and regulations, domestic and international.
  • Responsible for development of regulatory strategies and testing plans to provide for 510(k), BLAs, INDs, CE marking and foreign product approvals with minimal time delays and minimal expense. Responsible for monitoring progress to plan and develop strategies as required.
  • Responsible for review of all labeling, advertising, promotional material, and technical publications for compliance and product liability concerns.
  • Provides analysis of impact and comments on new regulatory requirements and national and international standards. Advise on adjustments to company procedures and design requirements, as necessary.
  • Responsible for administering the Engineering Document Control (EDC) policies and procedures in accordance with Quality System Regulations and ISO requirements.
  • Responsible for reviewing all labeling, advertising, promotional material, and technical publications for compliance and product liability issues.
  • Responsible for representing the company in industry associations such as OSMA and HIMA, and standards organizations such as ASTM and ISO.
  • Responsible for preparation of budget in support of regulatory affairs activities.
  • Responsible for developing and mentoring the RA department to create an effective and efficient responsive team.
  • Responsible for providing regulatory guidance to the site leaders, internal customer and cross functional teams.
  • Represents the company in industry associations, standards organizations, and corporate regulatory group meetings.
  • Provides regulatory direction and oversight on a global basis
The Senior Director of Regulatory Affairs Qualifications:
  • Bachelors degree in Sciences, Business, Engineering or equivalent with a minimum of ten years regulatory experience with a minimum of 5 at the Senior Manager or Director level
  • Extensive knowledge of FDA and international laws, regulations, and guidelines that MUST include submissions to UK and MHRA
  • Extensive experience with biologics and/or pharmaceuticals or drug regulatory affairs both engineering and regulatory applications
  • In-depth experience in dealing with FDA and international medical device regulatory agencies preferred
The Senior Director of Regulatory Affairs will lead a team located in Fort Worth, TX, headquarters for this group of products.