Regulatory & Quality Assurance - Vice President
Incredible Regulatory & Quality Assurance opportunity in growth stage medical device company!! BÂRRX Medical is a privately-held medical device company founded to develop solutions and change the standard of care for patients with Barrett's Esophagus, a precancerous change to the thin layer of tissue lining the esophagus. We are looking for a proven Vice President, Regulatory Affairs and Quality Assurance to direct and lead the Company to ensure that goals and objectives are met surrounding product quality and regulatory compliance while complying with company polices/procedures, and all regulatory requirements. This Leader will be responsible for creating and executing innovative global regulatory strategies that support product development and result in approvals for global commercialization. The ideal candidate will have experience in defining strategies for meeting and keeping post approval compliance. This position will also be responsible for regulatory documents, submissions, and compliance issues. The Leader will represent the company with domestic and international regulatory authorities, contractors and corporate partners and will also provide regulatory support for various departments, projects, and teams/committees. This position will manage direct reports. Position Requirements:
- B.S. degree in Engineering, or related field (Master's preferred)
- Minimum of eight years leadership experience in the FDA regulatory industry (medical device industry is preferred)
- Strong working knowledge of cGMP regulations, ISO guidance, and good laboratory procedures.
- Familiarity with International Regulatory requirements, with emphasis on Asian countries; China, Japan, Korea.
- Thorough understanding of validation principles, strong knowledge of FDA and ISO regulations and guidelines, and testing procedures; analytical and problem solving skills; supervisory skills and experience; strong communication skills (speaking and listening); technical writing; conflict resolution skills; computer literate; team building skills; and a desire to develop others through coaching and facilitation.
- Ability to drive cost reduction while continuously improving performance, as well as the ability to lead employees in making changes
- Ability to establish and track accountability of issues, goals, and personnel
- Skilled in the use of statistical techniques as applied to vendor, process and product quality control.
- Understanding of marketing, accounting, financial and business management principles.
- Involvement in and support of continuous improvement programs and process reliability improvement initiatives.
- Strong written and oral communication skills.
- Strong computer skills with specific skills in Microsoft Office
EOE
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