Responsibilities:
Position Responsibilities:
- 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
Requirements:
Basic Qualifications:
- 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.
Employing POEA Agency: YES HUMAN RESOURCES, INC. Landbased Agency
Office Address: 3F BT&T CENTER 20 E. RODRIGUEZ AVE, BAGUMBAYAN QUEZON CITY
Telephone Number: 911-1450 telefax
Email Address: rr@yeshumanresources.com
Website: www.yeshumanresources.com
Official Representative: RAMBERTO B SAAVEDRA
Status: Valid License
License Validity: 2/16/2010 to 2/15/2014
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