Summary

The Vice President of Regulatory Affairs, Quality Assurance, and Clinical Affairs will lead the strategy development and execution of all regulatory, quality assurance, and clinical programs and initiatives. This role will lead and mentor regulatory, quality, and clinical teams to ensure regulatory and quality compliance.

Essential Duties and Responsibilities 

  • Lead the Regulatory, Quality Assurance, and Clinical Affairs organization in the development and implementation of regulatory strategies, programs, and processes to gain product approvals

  • Develop regulatory and quality assurance strategies and implementation plans for the preparation and submission of new products and to ensure regulatory and quality compliance

  • Anticipate and interpret global regulatory changes and trends that may impact compliance status or represent significant business risk

  • Build collaborative and credible relationships with the FDA and other government agencies in the US and globally

  • Provide leadership and mentoring to a cross-functional regulatory, quality and clinical team that results in high performance and collaboration across the organization

‚ÄčKnowledge, Skill and Competency Requirements

To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

  • Experience in leading the regulatory, quality, and clinical organizations

  • Demonstrated experience in regulatory filings and submissions for US (510(k)) and other

    countries/regions

  • Ability to build relationships and have credibility and influence with a wide audience

    including medical doctors, nurse clinicians, engineers, statisticians, regulatory bodies and

    senior management

  • Prior experience working with the FDA in the Office of Compliance or Office of the

    Chief Counsel

  • Knowledge of FDA Current Good Manufacturing Practices (cGMP), Good Laboratory

    Practices (GLP), Good Documentation Practices (GDP) and ISO 13485-2012 is required

• Demonstrated experience in leading and developing cross-functional regulatory, quality, and clinical teams

Education/Experience

  • Bachelor's degree required; MBA or Master’s degree in related field

  • Minimum of 15 years progressive experience in leading regulatory, quality and clinical

    affairs

  • Medical device industry experience highly preferred

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