ASP Global
Position Summary
The Senior Manager, Regulatory Affairs will own and drive all regulatory activities across the product lifecycle for our regulated products portfolio. The role will ensure compliance with U.S. regulations (e.g., 21 CFR Part 820) and global standards (e.g., ISO 13485, ISO 14971), support future expansion into international markets and higher classification devices, and serve as a strategic regulatory partner to senior leadership. This person must be self‑motivated, comfortable working in a lean environment, and able to set up processes as the company scales.
Key Responsibilities Regulatory Strategy
Assess the U.S. regulatory impact of changes, including product classification, submissions (i.e., 510(k)), labeling, and product claims
Develop regulatory strategies for market expansion of products beyond the U.S., 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
Regulatory Operations
Maintain U.S. FDA device and drug registrations and listings for medical devices, drugs, and biologics, for ASP and as U.S. Agent for designated contract manufacturers
Ensure compliance with 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
Regulatory Submissions
Prepare and submit regulatory dossiers globally to support business objectives, including 510(k)s, Canadian MDLs, EU Tech Docs/DoCs, 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
Post‑Market Surveillance
Oversee post‑market regulatory activities: complaint handling, vigilance/adverse event reporting, field corrective actions/recalls, health hazard evaluations, trend analysis, product surveillance
Leadership & Collaboration
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
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Legal
Industries
Medical Equipment Manufacturing
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Key Responsibilities Regulatory Strategy
Assess the U.S. regulatory impact of changes, including product classification, submissions (i.e., 510(k)), labeling, and product claims
Develop regulatory strategies for market expansion of products beyond the U.S., 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
Regulatory Operations
Maintain U.S. FDA device and drug registrations and listings for medical devices, drugs, and biologics, for ASP and as U.S. Agent for designated contract manufacturers
Ensure compliance with 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
Regulatory Submissions
Prepare and submit regulatory dossiers globally to support business objectives, including 510(k)s, Canadian MDLs, EU Tech Docs/DoCs, 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
Post‑Market Surveillance
Oversee post‑market regulatory activities: complaint handling, vigilance/adverse event reporting, field corrective actions/recalls, health hazard evaluations, trend analysis, product surveillance
Leadership & Collaboration
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
Seniority Level
Mid‑Senior level
Employment Type
Full‑time
Job Function
Legal
Industries
Medical Equipment Manufacturing
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