Associate VP, Regulatory Affairs

Lumenis Inc   •  

Denver, CO

Industry: Pharmaceuticals & Biotech

  •  

8 - 10 years

Posted 58 days ago

This job is no longer available.

PRIMARY FUNCTIONS

  • Manages & oversees the Global Regulatory Affairs department and associated processes for preparation of product submissions, including IDE, 510(K), CE Technical Files (MDD and MDR), China, Canada, Japan, South Korea, and Australia.
  • Interface with Ministry of Health for Canada, Japan, China, South Korea and Rest of World agencies for strategy and submissions as required from inception to approval.
  • Interact with FDA, including preparation of IDE/510(K) and De Novo submissions.
  • Manages the relationship with Notified Bodies, international regulatory agencies and related regulatory agencies for non-diplomatic countries.
  • Partnership with Business Groups and R&D to develop global approval strategies.
  • Collaborate with EU, China, Japan, South Korea, and Taiwan regulatory teams to develop global regulatory strategies.
  • Provide regulatory advice and guidance to Business Groups, R&D and project teams to ensure submissions meet regulatory requirements and maintain up-to-date knowledge of regulatory requirements.
  • Will support and partner with R&D, Engineering and Manufacturing functions in all phases of design, development, production and distribution of medical devices.

ESSENTIAL DUTIES & RESPONSIBILITIES

  • The principal Regulatory Affairs representative with cross-functional interface, partnership and collaboration responsibilities with key departments such as Business Groups, R&D, Clinical Affairs and Engineering.
  • This position fosters a global view on cross-functional teams, and mentors and provides guidance to regulatory representatives.
  • Independent decision-maker on global and the local issues for Yoqne'am, Israel reporting to the VP, Global Regulatory and Quality.
  • Provides regulatory advice on internal or partnered development assets.
  • Direct interface & collaboration with the Director, Global Quality Systems on strategies & tactical direction(s).
  • Independently leads the preparation, coordination or monitoring of regulatory submissions.
  • Leads the formulation of registration strategies for products/projects. Ensures US, EU, China registration strategies are designed and captured in the Global Regulatory Affairs Strategy Plan. Ensures implementation of the strategy. Ensures registration strategies adhere to corporate objectives.
  • Plan, review and approve required documents from various departments for filing of required information to FDA, original / supplemental filings, CE (MDD, MDR), China, Japan, South Korea, Taiwan, Australia and other International countries.
  • Provide regulatory review of study protocols, investigator's brochures, labeling, promotional materials and integrated summary documents.
  • Examines & strategizes complex matters where analysis of situations or data requires an in-depth evaluation of multi-variate factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining timely & favorable results.
  • Ensures budgets, schedules and performance requirements are met.
  • Responsible for ensuring that policies and procedures conform to applicable laws and regulations.
  • Interface with Director, Quality on audit activities in all locations (Israel, Frankfurt, Salt Lake City, Italy), and other facility locations as appropriate with collaborative interaction.
  • Researches and reviews laws, regulations and standards that affect operations and compares them to current corporate policies. Works in conjunction with R&D and Engineering on planning and implementing as appropriate to ensure compliance.
  • Stays abreast of potential legislation that may affect operations and collaborates with Business Group for review, planning and implementation.
  • Develops and oversees programs, which promote compliance with new laws.
  • Assists operating areas in developing and revising affected policies and procedures to ensure compliance with applicable laws.
  • Coordinates in conjunction with the Legal and Auditing areas, appropriate compliance programs for implementation in affected areas.
  • Assists in Risk Management Activities, Quality Engineering and labeling.
  • This position works with a high level of independence and autonomy, has a high degree of latitude to manage workload, takes initiative and defines direction without needing guidance. This position acts as a coach in a matrix team environment, and motivates self and others to complete projects on time.

Qualifications

  • Requires a Bachelor's or Master's Degree in related field.
  • Minimum of 8-10 years of experience in medical device sector.
  • Demonstrated working knowledge of medical and scientific principles.
  • Must have excellent interpersonal, collaboration skills with demonstrated ability to collaborate and be a partner with R&D, Clinical Affairs and Engineering.
  • Must have capability to lead cross department projects with strong project management skills.
  • Proven mastery & demonstrated understanding of all regulatory affairs aspects related to medical devices.
  • Experience in business or operations side of a medical device company is preferred.
  • Proven mastery of all aspects of the quality process, including standards, methods, and procedures.
  • Direct experience with Class II/III medical devices.
  • Experience with cGMP/QSR, ISO 13485, and Council Directive 93/42/EEC.
  • Solid organizational, analytical, and problem solving skills.
  • Very strong communication skills (both verbal & writing).
  • Ability to work through others.
  • Strong computer skills and a high attention to detail.
  • Demonstrated management and leadership skills with the ability to manage a global organization with team members in multiple countries.
  • Experience working in a medium size global company is preferred.
  • Be able to work in a matrix organization.
  • Must be willing to travel 50% to our corporate office (Israel) and other US/International sites.