Senior Manager, Regulatory Affairs - Heart Valve Therapy

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Location
Irvine, CA
Job Type
Direct Hire
Date
Jan 09, 2018
Job ID
2551968
GR Identifier: $Medd


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The Regulatory Affairs Sr. Manager role represents an excellent opportunity to join a high growth, innovative and industry leading organization and advance a career in the Regulatory Affairs function. In this role you will be part of a high performing Regulatory Affairs team responsible for the regulatory process to support Heart Valve Therapy products.
 
The successful candidate will represent Regulatory Affairs on a diverse array of regulatory initiative teams, manufacturing support, and new product development, with the goal of commercializing new technologies, as well as ensuring the sustained success of marketed products. The candidate we seek will demonstrate the ability to develop a variety of solutions to regulatory challenges and will exercise independent judgment in determining and communicating appropriate regulatory action and requirements. This role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans.
 
The Regulatory Affairs Sr. Manager will collaborate with cross-functional teams, make presentations to management teams, and mentor Regulatory Affairs team members to share regulatory affairs knowledge.
 
Additional Responsibilities may include:
  • Interact with the FDA and other approval authorities to negotiate evidence needs, and facilitate global approval of emerging technologies and changes to existing approvals.
  • Prepare, provide direction and oversee document packages for submission to global regulatory agencies. These could include Pre-Submission 510(k), IDE, PMA, Annual Reports, CE submissions and change notices.
  • Manage new or existing regulatory initiative projects such as electronic IFU, global labeling programs, EU MDR transition, etc.
  • Represent RA in external and internal audits or regulatory inspections, and compliance initiatives.
  • Represent RA through a committed partnership with R&D, Manufacturing, Marketing, Quality and Clinical Affairs throughout all phases of the product development process.
  • Responsible for regulatory review for promotional material, claims support of labeling content, product and process changes, and product documentation.
  • Monitor current/proposed regulations and guidance to advice on the potential impact to projects.
  • Manage and / or mentor the Regulatory Affairs team.
  • Monitor proposed and current global regulations and guidance; advise on impact of such regulations and guidance on the company within the scope of assigned projects.
  • 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 delays in schedules and/or operations and may jeopardize overall business activities.
Qualifications:
  • A Bachelor’s degree is required, preferably in a scientific discipline.
  • Requires a minimum of twelve years’ experience in Regulatory Affairs; minimum of 10 years’ experience in RA with a Master’s degree.
  • Proven experience in interactions with regulatory bodies.
  • Experience in preparing FDA and EU product submissions required.
  • 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.
  • Requires a strong working knowledge of US and EU regulations that affect Class I, II and III devices; strong knowledge of global regulations a plus.
  • Demonstrated understanding of regulatory requirements for promotional materials; experience in review and approval of promotional materials is a plus.
  • Requires familiarity with new product development systems.
  • Requires the ability to travel 10% of the time.
  • Excellent writing and verbal communication skills across all levels
  • Strong strategic thinking, problem-solving and analytical ability.
  • Ability to multitask and balance competing priorities.