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Reference Number:
RASPA
Job Description:
****OUR FIRM IS OFFERING A $500 SIGN-ON BONUS!!! JUST IN TIME FOR THE HOLIDAYS!
This is for a large medical device company that is growing again. They do offer full relocation and experience with Women's Health products is a huge plus.
*Please note this client will not sponsor visas.
The position of the Regulatory Affairs Specialist reports to the Sr. Director, Quality/Regulatory/Clinical Affairs. The Regulatory Affairs Specialist provides expert regulatory and clinical support to the client's Business Unit. This position provides expert guidance in the development of clinical protocols, the preparation of IDEs, 510(k)s, PMAs and PMA Supplements. Additionally, this position is responsible for the development and review of new product promotional materials and device labeling. This position will work closely with management and the other RA/CA Specialists to help align the department objectives with the overall department activities. This position interfaces with multiple functional areas and geographies.
Responsibilities:
- Identify and manage CROs, clinical consultants, biostatisticians, data base managers, clinical investigators and all other outside resources needed in the development of clinical protocols and the conduct of clinical studies.
- Prepare, review and file appropriate FDA per market submission to ensure devices are commercially available in the U.S.: preIDEs, IDEs, 510(k)s, PMAs and PMA Supplements.
- Provide guidance in the development of clinical/statistical plans and review/finalize clinical/statistical reports.
- Development and document decisions not to seek FDA clearance/approval
- Review promotional material and labeling for regulatory compliance.
- Ensure all necessary internal and external training as needed to ensure the proper conduct of clinical studies
- Ensure coordination with clinical and development personnel on assigned projects.
- Develop and monitor necessary project plans and budgets
Experience Level:
5+ Years
Requirements:
Requirements:
Education: Bachelor's Degree (BS or BA), preferably in a technical discipline, life sciences field or related discipline.
Knowledge: Comprehensive knowledge of U.S. FDA regulations relating to (510(k)s, PMAs and the review of promotional and labeling materials. Demonstrated ability to develop an advanced technical knowledge of a company's products and their clinical application. Although this position does not require the candidate to personally develop statistical plan, the candidate must be able to understand the statistical plan and communicate with biostatisticians.
Experience: Minimum of five years experience in regulatory affairs addressing (510(k)s, preIDEs, IDEs, PMAs and PMA Supplements. Experience in the development of clinical protocols: identification of patient population, clinical end points, study work flow, etc. The ideal candidate will have knowledge of MRMC (Multi-Reader/Multi-Case) studies.
Travel: Position will require domestic and international travel approximately 3 days per month domestically and international travel approximately twice per year (5-10 days).
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