Overview

Job Summary

The Director of Regulatory Affairs, Post-Market Compliance, Instrumentation Laboratory (IL) provides strategic and operational leadership for global post-market regulatory activities supporting Werfen's Hemostasis and Acute Care Diagnostics portfolios. Reporting to the Senior Director of Regulatory Affairs, this position is responsible for ensuring worldwide regulatory compliance of commercially distributed products through effective management of vigilance reporting, field actions, post-market surveillance activities, regulatory assessments, and product lifecycle compliance programs.

The Director serves as the regulatory leader for post-market compliance activities and collaborates closely with Quality Assurance, Medical Affairs, R&D, Operations, Manufacturing, Supply Chain, and Commercial teams to ensure timely identification, assessment, communication, and resolution of product-related regulatory issues.

This position is responsible for building, developing, and leading a team of regulatory professionals and for establishing and continuously improving scalable processes that support regulatory compliance throughout the product lifecycle, while ensuring ongoing adherence to requirements of FDA, EU IVDR, UK MDR, Health Canada, TGA, ANVISA, and other global health authorities.

Responsibilities

Key Responsibilities

Global Regulatory Strategy & Product Lifecycle Leadership

• Develop and execute global regulatory strategies supporting post-market compliance and lifecycle management of commercially distributed products.
• Direct and oversee global vigilance reporting programs, ensuring timely assessment, reportability determinations, preparation, review, approval, and submission of adverse event reports in compliance with applicable regulatory requirements and reporting timelines across the United States, European Union, United Kingdom, Canada, Australia, Brazil, Japan, China, South Korea, and other international markets.
• Establish and maintain processes for regulatory assessment, escalation, and decisionmaking related to reportable events, health hazard evaluations, field actions, and product safety issues.
• Monitor evolving global regulatory requirements and implement process improvements necessary to maintain compliance.

Field Actions and Regulatory Risk Management

• Lead global regulatory activities associated with field corrections, removals, recalls, Field Safety Corrective Actions (FSCAs), Urgent Field Safety Notices (FSNs), Urgent Medical Device Corrections/Recalls, advisory notices, and product defect corrections.
• Provide regulatory leadership during product safety investigations and cross-functional risk assessments.
• Ensure timely communication and reporting of field actions to regulatory authorities and competent authorities worldwide.
• Partner with Quality and Medical Affairs in evaluating product safety issues and determining appropriate regulatory actions.

Post-Market Surveillance and Lifecycle Compliance

• Direct the global Post-Market Surveillance (PMS) program, including trend analysis, complaint monitoring, periodic reviews, and post-market surveillance reporting requirements.
• Oversee development and maintenance of Periodic Safety Update Reports (PSURs), Post-Market Performance Follow-up (PMPF) reporting and activities, and other postmarket regulatory deliverables required under global regulations.
• Provide regulatory oversight for sustaining on-market device activities, product modifications, manufacturing changes, software and test parameter updates, labeling updates, and product lifecycle management activities.
• Oversee preparation and approval of regulatory assessments ("Letters to File"), and global registration impact evaluations associated with changes to on-market devices.
• Review and approve protocols and reports supporting on-market device changes to ensure regulatory compliance and alignment with global registration requirements.
• Support global device lifecycle maintenance activities, including regulatory maintenance of product registrations, license renewals, and market authorization continuity across applicable jurisdictions.

Regulatory Operations and Compliance Excellence

• Ensure regulatory compliance processes are effectively integrated within the Quality Management System.
• Establish metrics and performance indicators to monitor effectiveness of post-market regulatory programs.
• Drive continuous improvement initiatives that strengthen compliance, improve efficiency, and reduce regulatory risk.
• Support internal audits, external audits, regulatory inspections, and notified body assessments related to post-market regulatory activities.
• Manage ongoing synchronization of global unique device identification (UDI) data fields across GUDID, EUDAMED, and emerging device tracking databases, and oversee North America facility registrations, including FDA Establishment Registration and Listing and Health Canada MDEL, while ensuring availability of supporting documentation for international facility registration requirements.

Budget Managed

• Responsible for developing budget for the RA post-market function, as part of annual business planning.

Qualifications

Qualifications & Experience required for the position:

• Education: Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, Chemistry, or a related technical discipline required. A Master's degree in Regulatory Affairs, Life Sciences, or a related field is strongly preferred. Regulatory Affairs Certification (RAC) is highly desirable.
• Industry Experience: Minimum of 10 years of progressive regulatory affairs experience in medical devices and/or IVDs, with significant experience in post-market regulatory compliance, vigilance reporting, and field actions, with a minimum of 5 years driving multidisciplinary teams.
• Leadership Experience: Demonstrated experience leading regulatory teams or major regulatory workstreams in a global, matrixed organization, including cross-functional leadership with Quality, Medical, Manufacturing,and Commercial functions.
• Regulatory Expertise: Strong working knowledge of global post-market regulatory requirements, including FDA MDR reporting and recall management, EU IVDR FSCA/vigilance and PMS requirements, UK MHRA requirements, and MDSAP jurisdiction requirements (US, Canada, Brazil, Japan, and Australia), as well as broader international regulatory frameworks
• Technical Experience: Experience supporting complex medical device systems, including instrumentation, reagents/consumables, and associated software or connected systems.
• Compliance & Inspection Readiness: Experience supporting regulatory inspections, audits, and interactions with health authorities or notified bodies in a post-market context.

Travel requirements:

• Up to 5%

The annual base salary range for this role is currently $200,000 to $240,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.