Regulatory Affairs Specialist

Position Summary

We are seeking a Regulatory Affairs Specialist with Regulatory Affairs experience to support our most complex products. This role is pivotal to ensure timely market access. The successful candidate will actively participate in cross-functional New Product Development teams with R&D, Marketing, Quality, Manufacturing, Supply Chain, and other departments to provide regulatory guidance throughout the product development lifecycle.

Essential Functions

Regulatory Submissions & Documentation

• Support the preparation and coordination of FDA regulatory submissions such as FDA Pre-Submissions, 510(k), De Novo, IDE, and BLA submissions for combination products.
• Maintain regulatory documentation and records to support product development and compliance.

New Product Development & Cross-Functional Collaboration

• Participate in cross-functional New Product Development (NPD) teams, collaborating with R&D, Quality, Marketing, Clinical, and other departments.
• Provide regulatory support for product development, labeling, and product modifications.

Regulatory Lifecycle Management

• Support post-market regulatory activities, including product changes, labeling updates, and compliance documentation.
• Maintain regulatory records and collaborate with internal teams to support ongoing compliance.

Clinical & Regulatory Integration

• Assist with reviewing clinical study protocols, reports, and related documentation for regulatory compliance.
• Support regulatory activities associated with clinical investigations.

Competencies

• Strategic Regulatory Leadership: Supports regulatory strategies and assigned regulatory initiatives.
• Regulatory Expertise & Compliance Management: Applies regulatory knowledge to maintain compliance and support regulatory requirements.
• Cross-Functional Collaboration & Influence: Collaborates effectively with cross-functional partners to achieve regulatory objectives.
• Executive Communication & Stakeholder Management: Communicates regulatory information clearly and professionally to key stakeholders.
• Critical Thinking & Problem Solving: Identifies regulatory issues and develops practical solutions with appropriate guidance.
• Project & Program Leadership: Coordinates assigned regulatory projects, timelines, documentation, and deliverables.
• Team Development & Mentorship: Supports team effectiveness through collaboration and knowledge sharing.
• Results-Oriented Execution: Delivers accurate, timely regulatory work while managing multiple priorities.
• Risk Assessment & Decision-Making: Identifies regulatory risks and applies sound judgment within established guidelines.
• Adaptability in a Dynamic Regulatory Environment: Adapts effectively to evolving regulations, priorities, and business needs.
• Integrity, Ethics & Accountability: Demonstrates integrity, accountability, and commitment to regulatory compliance.
• Continuous Learning & Innovation: Builds regulatory expertise and applies evolving requirements and best practices.

Minimum Qualifications

Education: Bachelor's degree in Engineering, Life Sciences, or a related technical field; advanced degree (MS, PhD, RAC) strongly desired.

Experience: Minimum of 2-3 years of Regulatory Affairs experience within the medical device industry, with a focus on Class II devices, or an advanced degree in Regulatory Affairs, Biomedical sciences, Engineering or related discipline. An equivalent combination of education and relevant experience will also be considered.

Knowledge, Skills, and Abilities

• Working knowledge of FDA regulatory requirements, including 510(k) submissions, with exposure to De Novo, IDE, or BLA pathways preferred.
• Experience supporting the preparation, review, and maintenance of regulatory submissions.
• Ability to collaborate with Clinical Affairs on clinical study documentation, protocols, and IRB/IEC submissions.
• Strong written and verbal communication skills with the ability to interpret and communicate regulatory requirements.
• Experience working with medical devices and knowledge of applicable regulatory requirements preferred.
• Strong organizational, analytical, and problem-solving skills with attention to detail.
• Ability to manage multiple assignments, meet deadlines, and work effectively with cross-functional teams.
• Proactive, adaptable, and capable of working independently with appropriate guidance.