Regulatory Affairs Specialist
2 days ago
As a Regulatory Affairs Specialist at Katalyst Healthcares and Life Sciences, you will play a critical role in ensuring the compliance of our medical devices with global regulatory requirements. You will develop and implement global regulatory strategies for new and modified medical devices, providing regulatory guidance to cross-functional partners and preparing and submitting regulatory submission documents for US and OUS regulatory filings.
Responsibilities
Develop and implement global regulatory strategies for new and modified medical devices
Provide regulatory guidance to cross-functional partners
Prepare and submit regulatory submission documents for US and OUS regulatory filings
Represent Regulatory Affairs on assigned project teams through all phases of product development and communicate regulatory requirements
Prepare Technical Files /Design Dossier, Change Notifications, and Submissions
Provide guidance and direction to ensure international product registration/licensing requirements are addressed and met
Ensure compliance with all relevant quality system regulations
Requirements
Direct experience with preparing Pre-Submission and interfacing with FDA personnel
Excellent knowledge and experience with global medical device regulatory requirements, design control, and product registration
Working knowledge of product development process
Ability to assess the changes to marketed products and their impact on product registration
Ability to identify, research, analyze technical documentation, and interpret governmental regulations
Excellent oral and written communication skills
Serve as regulatory liaison and work in cross-functional product development team
Capable of handling multiple tasks/projects and managing priorities accordingly
Effective interpersonal/communication skills
Works well under pressure in a dynamic timeline-driven environment
Extensive experience with MS Word and EXCEL
Regulatory Affairs Certification (RAC) preferred
What We Offer
Katalyst Healthcares and Life Sciences offers a dynamic and challenging work environment with opportunities for professional growth and development. We are committed to providing our employees with the resources and support they need to succeed in their roles and achieve their career goals.
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