Phagenesis · 22 hours ago
Director Global Regulatory Affairs
United States
Full-time
Remote
Director/Executive
10+ years expPhagenesis is a leader in the Clinical, Medical, Regulatory & Affairs function, seeking a Director of Global Regulatory Affairs. This senior role is responsible for developing and executing regulatory strategies across the product lifecycle, ensuring compliance and strategic guidance for the company's growth in the US and EU markets.
BiotechnologyHealth CareMedicalNeuroscience
Hiring Manager
Dennis Elmer
Responsibilities
Develop and execute global regulatory strategies that support current and future products, indications, and business objectives in the US, EU, and other target markets
Provide proactive regulatory guidance and scenario planning to senior leadership and cross-functional teams
Identify applicable regulatory standards and requirements, and establish systems, processes, and tools for standards monitoring, tracking changes, and conducting gap analyses
Lead and oversee the preparation, coordination, and submission of regulatory filings, including:
US: 510(k), De Novo, IDE, Q-Submissions
EU: Technical files, design dossiers, CE certification documentation, CER management
Ensure all submissions are high-quality, timely, and aligned with agency expectations
Maintain lifecycle regulatory documentation across multiple jurisdictions
Ensure product, labelling, and promotional compliance with local regulatory requirements
Oversee post-market surveillance, vigilance reporting (including FDA Medical Device Reporting), trending, and risk-based compliance activities
Partner closely with Quality to support audits, inspections, and ongoing QMS governance
Serve as the primary regulatory contact with the FDA, Notified Bodies, and other global regulatory authorities
Lead regulatory negotiations, pre-submission meetings, and strategy discussions
Build and maintain strong, constructive agency relationships to enable successful approvals and market expansion
Collaborate with R&D, Quality, Clinical, Operations, and Marketing teams to ensure regulatory requirements are embedded across the product lifecycle
Provide expert regulatory input during design controls, risk management, clinical planning, labelling development, and product changes
Identify, assess, and communicate regulatory risks across development and commercial programs
Develop mitigation plans that balance compliance, innovation, and business needs
Support leadership decision-making with clear regulatory pathways and risk-benefit recommendations
Qualification
Required
10+ years in medical device regulatory affairs, including global strategy and lifecycle management
Deep expertise in US FDA and EU MDR, including 510(k), De Novo, IDE, Q-Submissions, technical files, and CE certification
Strong understanding of FDA QSR (21 CFR 820 & QMSR), ISO 13485, and MDSAP with direct compliance experience
Proven success leading regulatory submissions and direct interactions with FDA and Notified Bodies
Experience managing post-market surveillance, vigilance reporting, and labelling compliance
Ability to identify applicable standards, conduct gap analyses, and implement systems for standards monitoring
Cross-functional leadership experience across R&D, Clinical, Quality, Operations, and Commercial teams
Leadership of complex regulatory programs within a dynamic, scaling medical device environment
Preferred
Experience with neuromodulation, electroceuticals, or Class II/III medical devices
Prior work in US commercialization pathways, including market access or reimbursement considerations
Experience supporting clinical investigations and evidence-generation strategies
Familiarity with additional global regulatory frameworks (e.g., Canada, Middle East)
Experience preparing organizations for FDA inspections or Notified Body audits during scale-up
Prior responsibility for regulatory team management or mentoring
Experience working in a matrixed CMRA function alongside Clinical, Medical, and Quality leaders
Exposure to post-acquisition or IPO-readiness environment
Company
Phagenesis
Phagenesis is engaged in the development of a device to treat dysphagia, a condition that disables the safe swallowing of food.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$71.4MKey Investors
MedTech InnovatorInventages Venture Capital Investment Inc.
2024-03-04Series D· $42M
2022-06-07Non Equity Assistance
2016-09-02Acquired
Leadership Team
Chad Hoskins
Chief Executive Officer
Scott Grant
Vice President Therapy Development
Recent News
2025-05-04
2025-04-02
Company data provided by crunchbase