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Senior Clinical & Regulatory Affairs Specialist

KeyTalent Miami, FL
  • Expired: 18 days ago. Applications are no longer accepted.

KeyTalent is partnered with an amazing Medical Device company in Miami seeking a Senior Clinical & Regulatory Affairs Specialist to join their growing team! This is a FULL-TIME, DIRECT-HIRE opportunity that comes with excellent benefits and room for growth.

This position requires a self-motivated team player with good problem-solving skills, practical knowledge and common sense. The nature of work requires a precise, thorough and meticulous person who takes initiative to solve challenges as they arrive.

Essential Duties & Responsibilities:

  • Manage study-related product provision to site according to local process
  • Understand and keep updated with regulatory developments relevant to BM US products
  • SOP training as required
  • Organize cadaver labs/ create lab report
  • Create post-market clinical follow-up studies
  • Review design review documents for clinical feasibility, apply required changes
  • Responsible for the execution of the company's US Complaint Management process as assigned by product or region

Required Qualifications

  • Working knowledge of clinical research design and execution in medical device search
  • Strong project management skills
  • Sound knowledge of ISO14155
  • Experience with trial audits an asset
  • A Bachelor’s Degree, preferably in a medical or engineering field with an emphasis on statistics and trend analysis is required.
  • Prior Medical Device or Pharmaceutical industry experience is highly desired.
  • Prior complaint management, post market vigilance, risk management, or compliance experience.
  • The ability to work individually as well as on a team.
  • Ability to work an extended period of time on a computer. Ability to communicate effectively
  • verbally and in writing (technical and persuasive).
  • Up to 10% travel may be required to support process improvements and audits.
  • Bachelor’s degree
  • Excellent interpersonal skills
  • Excellent written and oral communication. Ability to interface with both technical and non-technical personnel at all organizational levels
  • Excellent organizational, problem-solving, attention to detail, analytical, and time management skills
  • 1-2 years’ experience in medical devices, biologics and/or pharmaceutical field desired (preferred)
  • Training and/or certifications in regulatory affairs preferred Preferred Qualifications
  • Understanding of monitoring, data management, and statistical analysis
  • Excellent communication and presentation skills
  • Clinical designation/certification (CCRA, CCRC, CCRP) is an asset
  • A Green Belt (Six Sigma) or other formal Investigation Training is preferred, with a Black
  • Belt (Six Sigma) or CQE (ASQ) certification or equivalent is strongly preferred. Experience with MS Office, Minitab, Siebel, and SAS.
  • Knowledge of applicable and international regulations and standards preferred

KeyTalent

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