Senior Regulatory Specialist

We are seeking an experienced Senior Regulatory Specialist with strong expertise in Medical Device Regulatory Affairs to support regulatory activities across the product lifecycle. The ideal candidate will have at least 7 years of experience in medical device regulatory affairs , with demonstrated expertise in regulatory change assessments, U.S. medical device submissions, regulatory strategy, and cross-functional collaboration .

This role will serve as a key regulatory representative supporting new product development, marketed products, manufacturing changes, labeling activities, and ongoing regulatory compliance.

Key Responsibilities

• Perform and lead regulatory change assessments to determine the regulatory impact of product, manufacturing, process, and design changes.
• Support and provide regulatory guidance for U.S. medical device submissions and regulatory activities.
• Develop and implement regulatory strategies to support new product development and lifecycle management.
• Ensure timely regulatory approval and continued compliance for new and marketed medical devices.
• Serve as the Regulatory Affairs representative on cross-functional teams involving R&D, Quality, Manufacturing, Engineering, Clinical, and Marketing.
• Advise development and marketing teams regarding manufacturing changes, product changes, line extensions, labeling, and regulatory requirements .
• Participate in regulatory assessments related to product changes, technical documentation, and product lifecycle activities.
• Support continuous improvement initiatives within Regulatory Affairs and related business processes.
• Contribute to product planning and implementation activities from a regulatory perspective.
• Provide regulatory input into risk management activities and evaluate potential regulatory impacts.
• Monitor regulatory requirements, industry developments, and applicable regulatory guidance to support regulatory intelligence and policy activities .
• Support maintenance of regulatory approvals and ensure marketed products remain compliant with applicable requirements.
• Collaborate with internal stakeholders to identify regulatory gaps, develop appropriate strategies, and resolve regulatory issues.
• Prepare, review, and maintain regulatory documentation in accordance with applicable procedures and requirements.
• Communicate regulatory requirements and recommendations effectively to technical and business stakeholders.

Required Qualifications

• 7+ years of professional experience in Medical Device Regulatory Affairs.
• Strong experience performing regulatory change assessments .
• Working knowledge of U.S. medical device regulatory requirements and submissions .
• Experience supporting regulatory activities throughout the medical device product lifecycle .
• Strong understanding of regulatory strategy, product changes, manufacturing changes, and labeling.
• Experience working with cross-functional teams in a medical device environment.
• Strong analytical, documentation, communication, and problem-solving skills.
• Ability to independently assess regulatory requirements and provide sound regulatory recommendations.

Preferred Experience

• Experience with FDA/CDRH regulatory submissions .
• Experience supporting new product introductions, line extensions, and marketed product changes.
• Experience with regulatory impact assessments and regulatory intelligence.
• Familiarity with medical device quality and risk management processes.
• Experience working in an FDA-regulated medical device environment.