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ID 271 Regulatory Affairs Specialist Job
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| Employer Name: |
SpiderID: 2216491 |
| Location: Portland, Oregon |
Date Posted: 5/7/2008 |
| Wage: $70k-$75k |
Category: Medical/Health |
| Job Code: |
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Job Description:
POSITION SUMMARY:
Prepare pre-market submissions to the FDA in accordance with applicable requirements and guidelines. Support activities associated with compliance with FDA regulations and guidelines associated with 510(k), IDE, PMA and PMA Supplement submissions.
ESSENTIAL FUNCTIONS:
Prepare product submissions to the FDA, including PMAs, PMA Supplements, IDEs and 510(k)s.
Prepare clear and concise product descriptions for submission to FDA including principles of operation, safety warnings, precautions and any contraindications.
Research competitive product approvals and emerging FDA requirements to support timely approval of submissions and department objectives.
Determine design validation and qualifications test requirements for new product FDA submissions and provide written guidance on these matters to design engineering and validation personnel.
Review design validation and qualification test results and prepares clear and concise summaries for submission to FDA.
Proofread translations for accuracy, readability and grammar.
Review and prepare software development, verification, and validation documentation and reports for FDA submissions. Gain knowledge of FDA software policies to assist in developing strategies for future submissions.
Prepare and update technical manuals and other product labeling as necessary to comply with FDA requirements; review labeling generated for compliance with FDA and company requirements.
Interface with Regulatory Affairs counterparts, engineering and development personnel
Work with other departments to facilitate, communicate and implement regulatory submissions strategies.
Gain knowledge of corporate standard operating procedures as they apply to division processes and FDA requirements.
Other duties as assigned.
TRAVEL REQUIREMENTS:
Limited travel is required, usually less than ten percent a year.
Please contact Ira Duesler at 315-853-3903 x 103 or send Word formatted resume to iduesler@grnutica.com. Refer to job ID 271 Regulatory Affairs Specialist.
Job Requirements:
POSITION Requirements:
Bachelors degree (or equivalent) in biomedical or electrical engineering, or related science.
Two years medical device and/or FDA experience.
Positive attitude and willingness to work on a team.
Ability to work independently and as a team leader.
Technical writing experience desirable.
Excellent computer skills, knowledge of Microsoft Office package, Windows and e-mail systems.
Excellent communication skills and the ability to work with all levels of the Company.
Strong organizational skills and attention to detail.
Job Criteria:
Start Date:
Position Type:
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: Ira Duesler |
Company Type: |
| Company: |
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| City: Clinton |
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| State: New York |
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| Zip: |
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