Regulatory Affairs Associate
(Job Code: RA008)
ACON Laboratories, Inc. develops and manufactures a broad range of rapid diagnostic and medical devices. ACON has led the way in making point of care medical diagnostics more affordable to more people worldwide, and the ACON name is well known in over 100 countries.
We are looking for a highly motivated individual to work in our Regulatory Affairs department to assist with coordination of the accumulation of technical information and prepare submissions for therapeutic, medical, or diagnostic device licenses to various governmental regulatory agencies.
Requirements:
- Bachelor’s degree in related discipline, life sciences preferred.
- Minimum 3 years IVD industry experience.
- Ability to clearly communicate with peers and upper management, verbally and in writing.
- Knowledge of QSRs & ISO 13485. Knowledge of IVDD, MDD, CMDR, GMP, and 21 CFR.
- Requires excellent organizational skills and attention to detail with the ability to multitask. Must have general mathematics, basic algebra and statistical analysis skills and be able to interpret graphs.
- Experienced Microsoft Office skills: Word, Excel, and Power point.
This position is located in San Diego’s biotech community. As an employee you will enjoy our competitive benefits and compensation packages, as well as working in a supportive team environment. We invite you to consider a career with ACON Labs by sending your resume to hr@aconlabs.com. Please reference job code RA008.
