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ID 269 Regulatory Affairs Manager Job
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| Employer Name: |
SpiderID: 2216364 |
| Location: Portland, Oregon |
Date Posted: 5/7/2008 |
| Wage: |
Category: Medical/Health |
| Job Code: |
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Job Description:
POSITION SUMMARY:
Lead team of Regulatory Affairs personnel in preparation of pre-market submissions to FDA including 510(k), IDE, PMA and PMA Supplements in accordance with FDA regulations and guidelines. Develop personnel resources to facilitate more efficient preparation of FDA submissions and personal growth.
ESSENTIAL FUNCTIONS:
Lead Regulatory Affairs team in preparing product submissions to the FDA, including PMAs, PMA Supplements, IDEs and 510(k)s.
Work with upper management to develop business strategies to reduce time to market and ensure compliance with FDA regulations.
Plan, develop and write Standard Operating Procedures (SOP) to support the regulatory activities. Interact with personnel to implement the SOPs.
Monitor and maintain effective policies and procedures to assure compliance with FDAs establishment registration and device listing regulations as they apply to products.
Review and monitor the ongoing status of procedures for labeling products for US distribution. This includes both market released and investigational devices.
Mentor all members of Regulatory Affairs staff to ensure personal growth and establishment of sound company resources.
Review and comment on all submission files prior to sending them to FDA to ensure consistency of message throughout.
Lead team that prepares annual reports required for products and devices that have been approved through the PreMarket Approval (PMA) process.
Assist the Clinical department in creating submission strategies, developing and reviewing protocols.
Assist with personnel training regarding regulatory activities including new employee orientations.
Direct team that prepares clear and concise product descriptions for submission to FDA including principles of operation, safety warnings, and precautions.
Research competitive product approval status and emerging FDA requirements to support timely approval of submissions and department objectives.
Determine and communicate 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.
Participate in review and preparation of software development, verification, and validation documentation and reports for new product FDA submissions. Utilize knowledge of FDA software policies to assist in developing strategies for future products and submissions.
Interface with Regulatory Affairs counterparts as well as engineering and development personnel at corporate facility.
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 twenty percent a year.
Job Requirements:
POSITION Requirements:
Bachelors degree (or equivalent) in biomedical or electrical engineering, or related science. Masters degree in related discipline is desirable.
Five to seven years medical device and/or FDA experience.
Two to three years experience leading projects or teams.
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, attention to detail and ability to multi-task.
Contact Information:
| Contact Name: Ira Duesler |
Company Type: |
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| City: Clinton |
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| State: New York |
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| Zip: |
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