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ID 270 Regulatory Affairs and Compliance Specialist Job
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| Employer Name: |
SpiderID: 2216734 |
| Location: Portland, Oregon |
Date Posted: 5/7/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
POSITION SUMMARY:
Prepare pre-market submissions including 510(k), IDE, PMA and PMA Supplements in accordance with FDA regulations and guidelines. Support activities associated with compliance to FDA regulations and policy including quality system requirements and other associated legal and ethical concerns.
ESSENTIAL FUNCTIONS:
Prepare product submissions to the FDA, including PMAs, PMA Supplements, IDEs and 510(k)s.
In cooperation with the other departments; plan, develop and write Standard Operating Procedures (SOP) to support the company compliance program. Interact with other personnel to implement the SOPs.
Monitor and maintain effective policies and procedures to assure compliance with FDAs tracking, complaint handling and Medical Device Reporting (MDR) regulations as they apply to products. This monitoring may be realized by a role in the Complaint Review Committee (CRC) and review of complaint files.
Perform periodic internal audits of all activities that are affected by FDA regulations or other requirements (i.e., Code of Ethics).
Review and monitor the ongoing status of company procedures for labeling products for US distribution. This includes both market released and investigational devices.
Participate in FDA facility inspections and support corporate during FDA foreign inspections, as required.
Assist in preparation of annual reports required for products and devices that have been approved by pre-market approval (PMA) process.
Assist the Clinical department in maintaining procedures for compliance with investigational study regulations and in facilitating validation of databases. Work with management to develop strategies for addressing compliance requirements for clinical studies and regulatory submissions.
Assist with personnel training regarding compliance activities including new employee compliance orientation.
Prepare clear and concise product descriptions for submission to FDA including principles of operation, safety warnings, and precautions.
Oversee, monitor and provide training of personnel in compliance to Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Participate in Corrective and Preventative Action (CAPA) system.
Research competitive product approval status 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 new product FDA submissions. Utilize 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 and 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.
Job Requirements:
POSITION Requirements:
Bachelors degree (or equivalent) in biomedical or electrical engineering, or related science.
Three 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.
Please contact Ira Duesler at 315-853-3903 x 103 or send Word formatted resume to iduesler@grnutica.com. Refer to job ID 270 Regulatory Affairs and Compliance Specialist.
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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