Regulatory Affairs Director

This company is a global leader in advanced molecular testing solutions. They are seeking a Regulatory Affairs Director who can lead global regulatory strategies for a portfolio of IVD products and manage a small team.  You will provide regulatory guidance to internal teams, while also interfacing with global regulatory agencies.  This company offers a competitive salary, comprehensive employee benefits, and a dynamic environment. Now is an exciting time to join this growing global organization!

Responsibilities:

  • Provide guidance to internal departments on developing strategies, policies, and procedures that ensure regulatory compliance and submission success for IVD products with global regulatory agencies.
  • Research and interpret global regulations, guidelines and precedents.
  • Define and execute global regulatory and submission strategies.
  • Partner with international leadership in conjunction with global business teams to plan, execute, and report on submissions.
  • Identify issues that may increase regulatory risks and propose strategies to address such risk.
  • Interface with regulatory agencies for pre-submissions, submissions, inquiries, and other issues.
  • Lead teams and interface with other departments to deliver on regulatory strategies and submissions for both new development and new intended uses for existing products.
  • Develop processes to accelerate approvals in the global markets.
  • Develop and manage global regulatory strategies and activities for submission, registrations and maintenance for a portfolio of IVD products.
  • Oversee the preparation and submission of 510(k)s and PMAs etc. to the appropriate regulatory agencies for assigned projects.

Knowledge and Skills:

  • BS degree in a scientific field.
  • At least eight years of regulatory affairs experience for diagnostics.
  • Regulatory experience with In Vitro Diagnostics required.
  • Experience leading and overseeing the preparation of US FDA 510(k) and/or PMA submissions for IVDs.
  • Extensive knowledge of requirements and processes for US regulatory approval of in vitro diagnostic medical devices. Ex-US regulatory knowledge is a plus.
  • Proven managerial experience of Regulatory Affairs across multiple countries in a remote management function.
  • Demonstrated organizational, planning and prioritizing abilities are required, as well as strong technical writing ability.
  • Demonstrated strong attention to detail; ability to work under pressure to meet deadlines.
  • Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.
  • Flexibility to adjust to changes in schedule, priorities, product availability.
  • Good verbal and written communication skills.

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