The search and recruitment firm, Yes Human Resources, Inc. is looking for, Regulatory Affairs Specialists.
- Write and manage regulatory submissions. This can include but not limited to regulatory regimes such as HSA, CE Mark, TGA, FDA.
- Provide regulatory affairs support for all aspects of product development and product manufacturing.
- Provide regulatory affairs support for clinical studies including pre-market, post-market and physician initiated studies.
- Perform regulatory responsibilities independently with a minimal level of guidance and supervision.
- Bachelor’s or higher degree in technical discipline.
- Minimum of 3 years of regulatory affairs experience.
- Prior knowledge of medical device regulations is an advantage.
- Experience with regulatory support of clinical trials.
- Excellent negotiation skills; written/oral communication skills.
- Strong team player and ability to work in a fast pace and cross-functional organization.
Closing date: March 26, 2012