Regulatory Affairs Associate at The Fountain Group

The Fountain Group is a national staffing firm and we are currently seeking a Regulatory Affairs Associate for a prominent client of ours.  This position is located in Santa Clara, CA Details for the position are as follows:
 
Job Description:
Details:

• Pay for this position is 40.00 to 45.00 hourly depending on experience.
• This position is a contract with the possibility of extension or conversion to permanent.

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. 
• Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). 
• Review/approval of engineering study protocols/reports and validation study protocols/reports. 
• Review and approval of manufacturing changes for Class III implantable medical devices. 
• May require an advanced degree and 5-8 years of direct experience in the field. 
• Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. 
• Relies on extensive experience and judgment to plan and accomplish goals. 
• Performs a variety of tasks. 
• May lead and direct the work of others. 
• A wide degree of creativity and latitude is expected. 
• Typically reports to a manager or head of a unit/department.