ARKRAY USA, Inc.
  • 15-May-2018 to 14-Jul-2018 (CST)
  • Regulatory
  • Washington, DC, USA
  • Full Time

Be involved with a company that is changing the lives of people across the globe.

ARKRAY is hiring a Vice President of Regulatory and Scientific Affairs to be responsible for programs and processes of regulatory applications of 510(k) and CLIA Waivers and to provide senior scientific leadership and technical direction for the Regulatory and Science teams.

Duties and Responsibilities 

  • Oversee and manage the preparation of regulatory submissions for 510(k) and CLIA Categorizations.
  • Negotiate with FDA and other regulatory authorities on regulatory application and approvals.
  • Draft and submit pre-submissions to FDA as necessary to clarify regulatory guidance.
  • Provide Research and Development Teams with strategic guidance and interpretation of FDA's regulatory requirements and regulations for the design and development of new products.
  • Recommend and Implement compliance strategies for existing, new and proposed products or product changes.
  • Coordinate with Research and Development Teams and Quality Systems to ensure that the Design Control documentation is created in alignment with the desired product performance claims.
  • Coordinate the requests for proposals for third-party organizational support such as Clinical Research Organizations (CRO's), clinical trial partners and specialty laboratory and testing services.
  • Oversee and manage the performance and clinical evaluation in US for FDA submission.
  • Act as the main point of contact between ARKRAY companies for new product development and changes to existing products.
  • Make decisions relating to selection, promotion, salary and discipline of employees.
  • Prepare budgets and manage ongoing monthly expenses and capital expenditures.
  • International travel required.

Knowledge and Skills 

  • Advanced Degree in Engineering, Chemistry, or other technical field.
  • Minimum of 10 years' experience in US regulatory submission for Class I and Class II medical devices, preferably laboratory and Point of Care IVD instrument and reagents.
  • Experience with Class III products preferred.
  • Proven experience with FDA GMP/QSR, ISO, and other regulatory issues related to medical devices.
  • Minimum of 8 years' experience in Quality Systems for medical products manufacturing, preferably medical diagnostics or devices.
  • Strong Experience of direct relationship and involvement dealing with FDA related to submission, preparation and follow up.
  • Experience with clinical study management.
  • Proven leadership and management skills, including ability to mentor and challenge staff of regulatory personnel and scientists.
  • Thorough understanding of design controls, clinical study requirements, quality system, and risk management.
  • Notable technical writing skills; ability to grasp and communicate strategic issues as well as tactical ones.
  • Computer skills such as Word, Excel, Power Point, Project.  

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities are encouraged to apply.

ARKRAY USA, Inc.
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