Sr. Regulatory Affairs Specialist - CIPS

Position Summary

The Sr. Regulatory Affairs Specialist - CIPS plays a critical role in driving material cost improvement initiatives aimed at optimizing product profitability and strengthening margin performance. Reporting into the Strategic Regulatory Affairs function, this position is responsible for developing and executing regulatory strategies and submissions to support Cost Improvement Projects (CIPS). The role ensures regulatory compliance while enabling material changes, managing documentation updates, supporting investigations, contributing to product development planning, and interfacing with regulatory authorities as needed.

This individual partners cross-functionally with Quality Assurance, Supply Chain, Commercial, and other Regulatory teams to align regulatory strategies with broader business and commercial objectives.

Principal Responsibilities

• Provide Regulatory support and serve as the RA Lead in the team driving Material CIP program.
• Support new supplier/vendor changes.
• Identify key risks on Material CIP Program and communicate appropriately into the Project Lead to ensure all regulatory impacts are captured for each project.
• Support the Program Lead in developing RA timelines in line with project charters and implementation plans.
• Collaborate with the appropriate RA functional peers to establish key risks and develop program implementation plans.
• Manage Technical Documentation.
• Manage Global regulatory impact assessments.
• Review and assess change control activities for potential impact on current regulatory filings
• Work with Program lead to estimate the resources and participants needed to achieve project goals
• Proactively manage changes in project scope, identify potential risks, and devise contingency plans
• Manage stakeholder communication to ensure project status and/or related issues are effectively communicated.
• Work with Quality, Operations, Engineering and other internal groups to investigate and recommend solutions to address potential regulatory issues.
• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks.

Education / Experience Requirements

• Advanced English level.
• Bachelor Degree in Science or Engineering disciplines.
• 5+ years of experience in the medical device industry, including at least 3+ years supporting Class II or higher device registrations in the US, EU, and Canada.
• 3+ years in knowledge and understanding of US, EU and Canada medical device regulations, standards, and guidance documents.
• Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required.

Specialized Skills / Other Requirements

• Experience with Corrective Action, Manufacturing and Design Control concepts desired.
• Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.)
• Positive attitude and ability to operate and communicate effectively with multiple teams & leadership
• Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change
• Excellent technical writing experience within a medical device environment – essential
• Attention to detail and accuracy – essential
• Ability to work well under deadlines and pressure
• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
• Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management.