Jobs

Description

Start Time (AM/PM)    8am
End Time (AM/PM)    5pm

Description / Summary:

We are seeking a highly skilled and experienced Regulatory Affairs Senior Specialist to join the Regulatory Affairs Operations team.

• This individual will serve as a key contributor to the centralized execution of international addendum labeling activities across client medical device portfolio.
• This role will lead complex addendum and supplemental labeling initiatives, partnering with Regulatory Affairs, Quality, Supply Chain, Packaging, Manufacturing, and international affiliates to ensure timely and compliant implementation of labeling changes.
• The ideal candidate will possess strong regulatory and quality system knowledge, project management capabilities, and the ability to influence stakeholders across multiple functions, geographies, and business environments.
• This individual must be comfortable operating independently, managing competing priorities, identifying risks, driving escalations, and developing addendum labeling strategies.

Key Responsibilities:

Initiatives include but are not limited to:

• Lead and execute addendum labeling requests for country-specific Instructions for Use (IFUs), import labeling, product-specific addendum labeling, and supplemental labeling, including preparation, review, and coordination of Universal Addendum Labeling (UAL) packages and supporting documentation.
• Own addendum labeling requests from initiation through implementation and release, developing and managing project plans, timelines, priorities, forecasts, and stakeholder communications to ensure on-time execution.
• Assess and apply regulatory, quality system, and business requirements to develop compliant addendum labeling strategies for complex product portfolios across multiple quality systems.
• Perform regulatory and quality system assessments for complex addendum labeling requests to determine implementation pathways, ownership, approvals, regulatory strategy, and compliance requirements, providing recommendations to support successful market implementation.
• Influence and collaborate with cross-functional stakeholders across Regulatory Affairs, Quality, Supply Chain, Manufacturing, and international affiliates to drive alignment, resolve issues, identify risks, communicate impacts, and escalate issues as needed to support business objectives and compliance requirements.
• Develop and improve addendum labeling procedures, work instructions, operational processes, and quality system integrations, while driving continuous improvement initiatives to improve compliance, efficiency, and scalability.
• Monitor emerging regulations and regulatory changes, evaluate potential impacts on labeling requirements and processes, and translate regulatory requirements into operational and quality system processes.
• Maintain project metrics, dashboards, forecasts, and status updates to support operational planning, resource allocation, and management reporting.

Minimum Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, Engineering, or related discipline.
• Minimum 6 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Compliance, Labeling, or related functions within a regulated industry.
• Significant experience in medical devices, pharmaceuticals, biotechnology, or combination products.
• Experience developing regulatory labeling strategies and leading complex post-approval labeling initiatives.
• Demonstrated experience managing cross-functional projects and successfully delivering results in global organizations.
• Experience owning labeling processes, change management activities, and process improvement initiatives.
• Proven ability to develop project plans, manage timelines, forecast workloads, and drive execution.
• Experience identifying risks, developing mitigation plans, and escalating critical issues appropriately.
• Strong knowledge of medical device quality systems and regulatory requirements.
• Excellent communication, stakeholder management, negotiation, and collaboration skills.

 Preferred Qualifications

• Medical device industry experience is strongly preferred.
• Experience supporting international labeling, addendum labeling, supplemental labeling, or labeling change management programs.
• Experience managing products across multiple quality systems, integration products, acquired product portfolios, or business alliance environments.
• Experience with third-party manufactured products, procured products, supplier quality management, and quality agreements.
• Experience developing quality system procedures, quality plans, work instructions, and process documentation.
• Experience with SAP, Adobe Acrobat Pro, power BI, Microsoft lists, SharePoint, document management systems, and regulatory databases.
• PMP certification or formal project management training preferred.
• Experience supporting global regulatory organizations and international affiliates.
• Experience developing KPIs, dashboards, reporting tools, and operational metrics.
• Demonstrated success leading initiatives in highly regulated global organizations.

Skills

• Independent
• Troubleshooting
• Critical thinker
• Regulatory Labeling Strategy
• Risk Assessment & Escalation Management
• Quality System Expertise
• Stakeholder Influence
• Diplomacy and Executive Communication
• Forecasting
• Process Ownership
• Ability to drive a problem through resolution and implement mitigations
• Ability to handle multiple streams simultaneously.