Description:
• Global Regulatory Affairs & Compliance Expertise: Strong understanding of international regulatory requirements and compliance frameworks, with the ability to assess emerging regulations and drive implementation across quality systems and business processes.
• Cross-Functional Leadership: Drives alignment and execution across Regulatory Affairs, Quality, Labeling, International Regulatory Affairs stakeholders, influencing without direct authority.
• Regulatory Operations & Project Management: Manages complex compliance initiatives, governance activities, and implementation programs with accountability for timelines, risks, and deliverables.
Years Experience: 5-7 Years
We are seeking an experienced Senior Regulatory Affairs Specialist to support the implementation of emerging global regulatory requirements across multiple franchises and international markets. This role is responsible for assessing regulatory changes, coordinating impact assessments, driving implementation activities, and ensuring regulatory requirements are effectively integrated into quality systems, processes, and business operations.
The ideal candidate will have experience in Regulatory Affairs, Regulatory Compliance, Regulatory Operations, Quality Systems, or Compliance within a regulated medical device environment and possess strong project management and stakeholder leadership skills.
Key Responsibilities
Emerging Regulatory Issues Implementation
• Lead pan-franchise implementation of emerging global regulatory requirements across international markets.
• Assess new or changing international regulations to determine business impact, implementation needs, risks, and timelines.
• Coordinate cross-functional gap assessments and implementation plans to ensure regulatory requirements are incorporated into quality systems, procedures, labeling processes, and business operations to support continued market access and compliance.
• Partner with Regulatory Affairs, Quality, Labeling, Supply Chain, Legal, and affiliate teams to drive timely and compliant execution.
• Monitor implementation activities, identify risks, and drive issue resolution to support on-time compliance.
Compliance Governance & Audit Readiness
• Support audit readiness activities across Regulatory Affairs functions by identifying compliance risks, quality system gaps, and remediation opportunities.
• Track audit observations, remediation activities, and compliance commitments through completion.
• Develop and maintain KPIs, dashboards, trackers, and governance reports to provide visibility into implementation progress, compliance risks, and key deliverables.
• Support regulatory audit readiness activities and participate in internal, external, and regulatory inspections as needed.
Cross-Functional Leadership
• Act as a key liaison between Regulatory Affairs, Quality, Regulatory Compliance, Labeling, and international affiliates to resolve complex regulatory challenges
• Facilitate cross-functional governance meetings and drive decision-making and accountability
• Influence stakeholders and align priorities across multiple functions and geographies
• Communicate implementation plans, risks, and progress updates to stakeholders and leadership.
• May serve as an interim lead for the Emerging Issues SME team, supporting prioritization, coordination, and execution of key activities.
Regulatory Operations & Documentation
• Lead change management activities associated with regulatory and procedural updates.
• Manage change order activities required to support regulatory and quality system updates.
• Support management of post-approval regulatory commitments and associated deliverables.
• Identify and implement process improvements to enhance efficiency, visibility, and compliance within regulatory operations.
• Maintain and enhance KPI dashboards / Management Review Metrics to ensure health of Product Approval Key Process
Required Qualifications.
• 5-7 years of experience in Medical device, pharmaceutical, biotechnology, or other highly regulated industry experience
Regulatory Affairs, Regulatory Operations, Regulatory Compliance, Quality Systems, Compliance, or a related function within a regulated medical device industry.
• Strong understanding of international regulatory requirements and global compliance frameworks.
• Experience supporting implementation of regulatory or compliance requirements across cross-functional organizations.
• Strong project management, organizational, and stakeholder management skills.
• Ability to work independently and drive initiatives with minimal oversight.
Ability to drive a problem through resolution and implement mitigations.
Ability to handle multiple streams simultaneously with timely execution.
