| Regualtory Affairs Project Manager |
Job Id: W308847 |
Posted On: 3/4/2010 |
|
Location: Fort Myers, FL;
Job Type: Full Time
Salary: $80000.00 to $120000.00/year
Degree: Bachelor
|
|
DescriptionOur client is a growing Medical Device manufacturer, located in a desirable area in Florida, with an opportunity for a Regulatory Affairs Project Manager. This position will be responsible for preparing and managing submissions for new products and changes to existing products FDA filings. This role must be filled by someone who understands compliance requirements of regulator affairs affecting company operations and products.
The Regulatory Affairs Project Manager will write and submit 510ks, as well as Canadian submissions, investigational device submissions, and PMAs. Will be responsible for managing junior level associates, assigning projects and mentoring them. May participate in Quality System audits, and may be involved with review and monitoring clinical and animal studies.
Requirements:
Bachelors degree a must, preferably in Science or Engineering
7 plus years of direct experience in Regulatory Affairs in a medical device company
Orthopedics experience a plus
Regulatory experience in the US a must, Canada and Europe preferred
RAC certification a plus
|
New Users - Register Here to Apply |
|
Returning Users - Login to Apply |
 | Post your resume |
| Create Career Alert emails to receive fresh jobs daily |
| Sign Up Now |
|
|
|
|
|
|