Regulatory Affairs Specialist
| Company: | CCSI Inc. |
| Posted: | 7/15/10 |
| Location: | Malvern, Pennsylvania |
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Description
There is a job opportunity located in Malvern, PA. The position is a Regulatory Affairs Specialist. If you are interested please review the job description below and respond today. Make sure you attach an updated MS word document resume and a number in which you can be reached on.
Job Description:
Performs full range of standard work for the professional field. Applies advanced skills to resolve complex problems not covered by existing procedures or practices independently. Identifies and resolves more complex problems and applies problem-solving skills in order to deal with most situations.
BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Performs the writing and filing appropriate FDA premarket submission to ensure devices are commercially available in the U.S. Completes the review of promotional material and device labeling for regulatory compliance. Completes regulatory projects, project schedules, and product introduction process. Completes decision making on regulatory submission issues using historical knowledge, legal counsel and FDA's current regulations on medical device industryDemonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.
Typically 5-8 years of successful experience in related field and successful demonstration of Key Responsibilities and Knowledge as presented above. Advanced degree MAY be substituted for experience, where applicable.
Provide general guidance or train support and/or professional staff.
Primarily intra-organizational contacts and external contacts.