Senior Regulatory Specialist III- Medical Device Class II and III - Clearwater, Florida United States - 39477

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JOB DESCRIPTION

Job #: 39477
Title: Senior Regulatory Specialist III- Medical Device Class II and III
Job Location: Clearwater, Florida - United States
Employment Type:
Salary: contact recruiter for details
Other Compensation: 5% bonus
Employer Will Recruit From: Regional
Relocation Paid?: NO

WHY IS THIS A GREAT OPPORTUNITY?


Company is an innovative medical device manufacturer in the field of advanced energy.  They are poised to be a solution focused company in the cosmetic surgery market and the broader medical technology sectors in 42 countries.  

This position is required to be in the office at least 2-3 times a week. 

JOB DESCRIPTION

Senior Regulatory Affairs Specialist III will be responsible for developing regulatory strategies for moderate to highly complex submissions to US FDA and/or international regulatory agencies; providing risk assessments of strategies and regulatory options to business teams and to product development/support teams; executing regulatory product submissions from the strategic planning stages through conduct/completion of clinical trials, submission to regulatory agencies and pre-market activities, as required; exercising considerable latitude in determining the manner in which to most efficiently organize activities to complete these submissions.

QUALIFICATIONS

Bachelor’s Degree (BA/BS) from a four-year College or University in a technical, regulatory, engineering and/or scientific discipline or equivalent regulatory/scientific experience; Advanced degree and/or RAC certification preferred.

EXPERIENCE

  1. Minimum 5-8 years of directly related regulatory experience in the medical device (Class II or III) arena.
  2. Solid knowledge of medical device regulations, 510(k) and/or Premarket Approval (PMA) process. Demonstrated success preparing, filing and completing (including internal and external negotiations) regulatory submissions (510(k), PMA, Technical Files and other regulatory documentation). Experience with US FDA Class II/III medical device submissions.
  3. Experience working directly with FDA, notified bodies and/or international health authorities.
  4. Experience interpreting subjective and complex aspects of specific regulations and thorough understanding of multiple sets of associated regulations.
  5. Experience supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
  6. Demonstrated success understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
  7. Experience analyzing complex issues and formulating cogent approaches to resolving/addressing issues.
  8. Knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations

Education:
University - Bachelor's Degree/3-4 Year Degree