Regulatory Affairs Specialist

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Regulatory Affairs Specialist

InGeneron is seeking a Regulatory Affairs Specialist for our Houston, Texas office to manage the regulatory aspects of our US-based international business, including obtaining and maintaining world-wide approvals, regulatory management of clinical trials, contributing to global regulatory strategy while effecting local regulatory strategy, being the regulatory voice for internal discussions and corporate processes, and liaising with regulatory agencies to effect the overall regulatory strategy.

Position Description:

  • Resident regulatory affairs authority for and primary regulatory contact for all corporate product lines and projects.
  • Provide input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submission and approval. Determine regulatory filing strategies and submission types.
  • Coordinate application materials for market approval/clearance submissions.
  • Review and make final determinations for regulatory assessments of proposed changes to existing products.
  • Read, review, interpret and keep current with regulations and publications regarding device, drug, biologic, and combination products with primary focus on medical devices.
  • Interact with domestic and international vendors and distributors/sales and international regulatory authorities to discuss regulatory issues and submission requirements.
  • Coordinate and facilitate meetings with regulatory agencies to determine and prepare agenda topics and meeting packages.
  • Provide regulatory guidance in the form of presentations on regulatory requirements to corporate management.
  • Provide regulatory guidance and support for clinical and non-clinical studies.
  • Participate in regulatory agency inspections such as ISO, QSIT, and cGMP inspections.
  • Manage vigilance and safety reporting for all marketed products and investigational studies.
  • Provide regulatory guidance and support for clinical and non-clinical studies.

 

Requirements: 

Candidates must possess at minimum a BS/BA in a scientific discipline plus 6+ years of experience in Regulatory Affairs with strong medical device manufacturing experience covering several regulatory specialty areas of concern: device registrations, quality system requirements, new product development, design controls, terminal sterilization of device products. etc.; experience in direct interaction with domestic and international Regulatory Agencies such as making presentations on proposed submissions and negotiating submission requirements where appropriate; Experience in analyzing and developing strategies for regulatory submissions to assure timely approval; creativity with respect to RA submissions and beyond; network of scientific and RA experts. An advanced degree, RAC certification, and experience with biologics and/or combination devices are desired. Candidates should have extensive knowledge of regulations governing the manufacture and marketing of medical products and of regulatory agency requirements and inspections.

Please e-mail your resume to careers@ingeneron.com or contact us at any time if you have questions.