Sr Manager, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapy

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Location
Irvine, CA
Salary
$150,000 - $180,000
Job Type
Direct Hire
Date
Dec 18, 2017
Job ID
2551929
GR Identifier: $Medd


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The Senior Manager, Regulatory Affairs role represents an excellent opportunity to join a high growth, early-stage product development group, Transcatheter Mitral and Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. This is a unique position to advance a career in the Regulatory Affairs function with an industry-leading organization. The successful candidate will represent the RA 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.
  • Represent regulatory affairs on product development and commercialization teams related to transcatheter mitral valve replacement programs.
  • Interacts with FDA and/or other regulatory bodies for submissions and projects.
  • Will monitor proposed and current US and EU regulations and guidance, and will advise the impact of such regulations and guidance on the company within the scope of assigned
  • Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.
  • Able to collaborate and take direction from team leaders, while working with RA management on RA strategy for US IDE, US PMA, CE Trial, CE Mark, as required.
  • Additional Responsibilities will include:
  • Prepares document packages for submission to global regulatory agencies (IDEs, PMAs, annual reports, 510(k) s and CE marking design dossiers and technical files). Prepare IDE and PMA annual reports and 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.
  • Work on multiple projects where analysis of situations or data requires an evaluation of intangible variables.
  • May work on new/emerging technology that has no or limited history.
  • Demonstrate the ability to develop a variety of solutions to regulatory challenges.
  • Exercise independent judgement 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 judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
  • Ensure schedules and performance requirements are met. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

Qualifications:
  • Requires a minimum of twelve years’ experience in Regulatory Affairs. Medical device experience in other areas, may be considered.
  • Experience in preparing domestic FDA and EU product submissions 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.
  • Demonstrated understanding of basic regulatory requirements for promotional materials.
  • Experience in review and approval of promotional materials is a plus.
  • 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.
  • Ability to travel 25 %