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VP of Quality & Regulatory Affairs

VP of Quality & Regulatory Affairs

Company Profile:

Our client is an ambitious and dynamic early stage medical devices and clinical technologies company with significant growth plans.

The company now wish to add to the executive team by appointing a VP of Regulatory Affairs with proven experience in the international FDA and regulatory arena.

Primary Responsibilities:

  • Plan, staff and supervise the RA/QA/QC organization which is expected to face significant product development and production growth over the next three years.
  • Interacts with all senior managers to assure coordination of efforts between functional departments as well as strict regulatory and ethical compliance
  • Monitor actions of global regulatory agencies and participate actively in policy discussions with industry and agencies.
  • Challenge clinical and regulatory issues / problems
  • Ensures that the Company deals fairly and ethically with its customers, employees, owners and vendors.
  • Integrate the medical scientific, business and governmental-regulatory elements of the Company to create an ethical and vigorous synthesis.
  • Develop and implement goal-directed efforts by regulatory and QA personnel
  • Lead Regulatory Affairs and QA function and develop, monitor and control department budgets.
  • Report to CEO and actively participate as a member of the leadership team

Skills, Qualifications & Experience:

  • Strong people management and relationship skills with a demonstrated ability to educate, guide team members as well as outside agency personnel.
  • Very strong relationship management and influencing skills
  • Position requires extensive technical and regulatory knowledge related to medical devices in general and heart valve therapies specifically.
  • Degree qualification in related medical and scientific fields or equivalent.
  • Medical device CA/RA/QA/QC management experience with quantifiable record of achievement.   Existing relationships with FDA
  • Substantial exposure to EFS Pathway Feasability studies
  • Related field graduate level degrees are an enhancement

A positive mindset, a can do attitude and self-sufficiency are very important considerations.

For more information, contact Liam at Harty Search on 061 414533.  You can email Liam also at liam@hartysearch.ie.