Manager, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies

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Location
Irvine, CA
Job Type
Direct Hire
Date
Jan 09, 2018
Job ID
2551952
GR Identifier: $Medd


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The Manager, Regulatory Affairs role represents an excellent opportunity to join a high growth, innovative and industry leading organization and advance a career in the Regulatory Affairs function. The successful candidate will represent the Regulatory Affairs function on a variety of Product Development Teams with a goal of commercializing a new and innovative technology.
 
The candidate we seek will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in determining appropriate regulatory action and requirements for product changes and preparation of regulatory documents. He/she may interact directly with Regulatory Agencies under management guidance.
 
Additional Responsibilities may include:
  • Prepares document packages for submission to global regulatory agencies (i.e., IDEs, PMAs, annual reports, 510(k)s and CE marking design dossiers and technical files).
  • Prepare IDE and PMA annual reports as well as Justifications to File.
  • Assume regulatory review of promotional material, labeling content, product and process changes and product documentation.
  • Act as liaison with government officials in support of product approvals.
  • Demonstrate the ability to develop a variety of solutions to regulatory challenges.
  • Exercise independent judgment in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents.
  • Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Ensure schedules and performance requirements are met.
  • Manage and mentor more junior members of the Regulatory Affairs team.
Qualifications:
  • Requires a minimum of ten years of experience in Regulatory Affairs. Medical device experience in other areas may be considered.
  • Experience in developing new product registration/dossiers for domestic FDA and EU product submissions is required.
  • A Bachelor’s degree is required, preferably in a scientific discipline.
  • Demonstrated competence in working as part of a focused project team.
  • Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
  • Experience in review and approval of promotional materials is a plus.
  • Experience in the cardiovascular device space is highly desirable.
  • Requires familiarity with new product development systems; a strong working knowledge of all U.S. regulations that affect Class II and Class III devices; a strong understanding of global regulations; excellent writing and verbal communication skills; and strong problem-solving and analytical ability.