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Job Title: Regulatory Affairs Specialist
Location – 22801 Roscoe Blvd., West Hills, CA 91304
Contract - 6 Months Contract
Job Description:
• A minimum of a Bachelor’s Degree in science or life science is required.
• Minimum of 3 years’ experience in the device/diagnostic area of regulatory affairs .
• Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards.
• Knowledge of Canadian and Japanese device regulations desired.
Responsibilities:
• Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests.
• Represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for global product development, labeling, and/or promotional issues.
• Attends product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis/risk assessment reviews, timeline development/reviews, and V & V reviews.
• Develops the regulatory strategy for project team(s).
• Applies advanced regulatory expertise to the evaluation and solution of submission problems.
• Actively reviews and edits documents associated with product development meetings.
• Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
• Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.
• Review and interpret scientific literature and summarize effectively in writing.
• Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.
• Ensure training and compliance with global quality system regulations.
• Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date.
• Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing
• Draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines
