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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


Why Work Here?

KeyTalent simplifies your career search!

KeyTalent, KeyStaff's Professional Placement Division, is the professional's answer to career search simplified! Our client's partner with the KeyTalent team in order to locate the most qualified and suited individuals for their needs. Our Candidates and Clients can count on KeyTalent to be diligent and communicative throughout the recruiting and hiring process!


Miami, FL