Every day, Kelly Scientific Resources (KSR) connects clinical research professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Regulatory Affairs Specialist working with our client based in Jacksonville, FL.
Represents Regulatory Affairs on product lifecycle teams by actively contributing to the development and implementation of regulatory strategies. Independently prepares and negotiates regulatory submissions for new products and product changes as required to ensure timely approval for market release. Performs tasks that support quality system compliance with US FDA Quality System Regulation and biologic regulations, other applicable international medical device regulations and ISO 13485.
Job Responsibilities (other duties may be assigned):
Prepares and submits product applications (510(k), BLA, PMA or their equivalent in foreign markets.
Respond to deficiencies and/or questions related to regulatory submissions.
Represents Regulatory Affairs on product lifecycle teams and on Product Development Process (PDP) projects.
Review and approve quality system documents to determine compliance with regulatory regulations and standards.
Review change orders for regulatory impact and domestic and international reporting requirements.
Develop regulatory strategies for implementation.
Evaluate complaint, deviation and data to determine the need for medical event reporting, field action or biological product deviation reporting.
Write and maintain departmental SOPs.
Recognize and elevate critical regulatory/compliance issues to management.
Assist with the administration of regulatory and third-part inspections.
Provide training and support to more junior members of the department as appropriate.
Bachelor's Degree required in scientific discipline.
1-3 years of direct biomedical regulatory experience is required.
One year medical device experience required OR if no Med device experience MUST have three years experience in a Regulatory environment within another industry.
One year FDA interaction experience preferred.
One year exp Writing and/or submitting 510(k)’s510k.
About Kelly Services ®
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class
staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually.
Revenue in 2012 was $5.5 billion.
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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...