Gena Monroy

Job Title: Regulatory Affairs Specialist 

Pay Range: $40

Work Schedule: Hybrid after 30 days Monday and Tuesdays on site, the third day candidate’s choice. 8:00am to 4:30pm 

We are seeking a Regulatory Specialist  for a 1yr term temporary position supporting our client, a global life sciences and clinical diagnostics organization! The Diagnostics Post Market Performance will be responsible to Assemble low to medium complexity regulatory submissions to support world wide product registration.  IVDR Technical file maintenance and monitoring of change requests.  Process improvements for SOPs related to full transition to IVDR.      Regulatory Affairs Specialist  job duties: 

• Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
• Ability to communicate effectively with employees across multiple departments
• Highly organized and detail-oriented. Good time management.
• Technical aptitude for understanding IVD product features
• Understanding of databases and electronic systems.

Regulatory Affairs Specialist  requirements:

• Education: BS in Biology or other scientific field
• Work Experience: 0-2 year’s experience in IVD regulatory affairs.
• Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)
• Laboratory research experience in an IVD medical device regulated environment is strongly preferred.
• Understanding of scientific reports, risk management, Quality Systems