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
- 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