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ASP Global · 1 month ago

Senior Regulatory Affairs Manager

Austell, GA

Full-time

Onsite

Senior Level

ASP Global is seeking a Senior Manager, Regulatory Affairs to manage regulatory activities for their product portfolio. This role involves ensuring compliance with U.S. regulations and global standards while providing strategic regulatory guidance to senior leadership and cross-functional teams.

Medical

Responsibilities

Assess the US regulatory impact of changes, including product classification, submissions (i.e. 510k), labeling, and product claims

Develop regulatory strategies for market expansion of products beyond the US, including device classifications, market access, and submission routes for new and legacy devices

Provide regulatory guidance to cross-functional teams throughout new product development

Conduct regulatory due diligence for Mergers & Acquisitions

Maintain US FDA device and drug registrations and listings for medical devices, drugs, and biologics, for ASP and as US Agent for designated contract manufacturers

Ensure compliance to UDI requirements, including maintenance of GUDID and other global UDI databases

Monitor and interpret global regulatory and standard changes and advise the organization on required actions

Review and approve device labeling, packaging, advertising, promotional materials, claims and instructions for use

Support Trade Compliance with FDA inquiries for timely importation of products

Support certification efforts and external audits

Prepare and submit regulatory dossiers globally to support business objectives, including 510(k)’s, Canadian MDL’s, EU Tech Docs/DoC’s, amendments, supplements, and other global submissions

Coordinate responses to regulatory authorities (i.e. FDA, Health Canada, Notified Bodies, Competent Authorities, other health authorities) and manage liaison interactions

Maintain accurate regulatory documentation, records, and submission tracking

Oversee post-market regulatory activities: complaint handling, vigilance/adverse event reporting, field corrective actions/recalls, health hazard evaluations, trend analysis, product surveillance

Lead and mentor the regulatory affairs function — hire/integrate team as needed, define roles and responsibilities, foster a culture of excellence and continuous improvement

Serve as the primary regulatory contact for regulatory agencies, notified bodies and customers

Work cross-functionally with R&D, operations, marketing, sourcing, and procurement to enable regulatory alignment with business objectives

Qualification

Regulatory strategy developmentRegulatory submissionsFDA compliancePost-market surveillanceGlobal regulatory knowledgeLeadershipCross-functional collaboration