Regulatory Specialist

About the Role

Kelly Science and Clinical FSP is seeking a Regulatory Specialist for a long-term engagement with a Global MedTech client. This role is part of the Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. The position is full-time and offers full benefit options.

Responsibilities

• Serves as a consultant and technical expert on Regulatory Affairs matters, providing assistance in preparation and submission of global regulatory documents with little to no supervision.
• Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or modified product launches, including site transfer activities.
• Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
• Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Defines data and information needed for regulatory approvals.
• Develops labeling specifications and approves proposed labeling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
• Provides Regulatory Affairs support during internal and external audits.
• Plans schedules for regulatory deliverables on a project and monitors progress through completion.
• Assists in the development of best practices for Regulatory Affairs processes.
• Represents Regulatory Affairs on cross-functional project teams.
• Partners with other functions to define and obtain data to assist with regulatory submissions.
• Authors and submits US, EU, and International Regulatory submissions to regulatory bodies.

Requirements

• Excellent written, verbal communication, and presentation skills.
• Deep scientific and technical understanding of regulated products to provide strategic guidance and support for product development and lifecycle management.
• Ability to integrate and execute results-oriented Regulatory Affairs strategies aligned with organizational objectives.
• Tactical and strategic regulatory knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class II and III devices (EU and USA 510k).
• Ability to partner and influence key stakeholders on New Product Development (NPD) and Lifecycle teams.
• Clearly defines and prioritizes decision criteria, considering benefits, risks, and organizational values before making decisions.
• Manages large amounts of changing, complex, and ambiguous information from multiple sources to make timely and effective decisions for project execution.

Leadership Competencies

• Connect: Encourages and supports internal collaboration across levels to create effective solutions; builds and leverages networks with colleagues, cross-functional partners, and industry contacts.
• Shape: Challenges the status quo and adapts to change; engages with regulatory agencies, industry groups, standards committees, and political/government agencies to influence external stakeholders.
• Lead: Leverages diverse perspectives and backgrounds to generate effective ideas or solutions.
• Deliver: Acts with speed, flexibility, and accountability to manage priorities and deliver results for on-time clearances.

Benefits

• Medical, Dental, and Vision coverage.
• 401K retirement plan.
• A variety of other benefits to choose from.
• Paid time off, including holiday, vacation, and sick/personal time.