Principal Regulatory Specialist

This role is accountable for ensuring regulatory compliance across the product lifecycle for the company’s current product portfolio while proactively enabling innovation, market expansion, and business growth.
Acting as a trusted advisor to cross functional leaders, the Principal Specialist provides deep regulatory expertise, interprets evolving regulations, and influences development strategy.

This individual contributor role is accountable for ensuring regulatory compliance across the product lifecycle while proactively enabling innovation, market expansion, and business growth. Acting as a technical advisor to cross-functional partners, the Principal Specialist provides deep regulatory expertise, interprets evolving regulations, and influences development strategy.

Accountabilities & Responsibilities
• Develop and execute regulatory strategies for new and existing products, aligning regulatory pathways with business objectives.
• Influence product development, portfolio planning, and lifecycle management decisions by identifying regulatory risks, opportunities, and early tradeoffs.
• Lead the preparation and technical review of regulatory submissions, including 510(k)s, q-submissions, and other global filings, as appropriate.
• Determine submission requirements and provide recommendations to ensure alignment across Engineering, Clinical, Quality, and Manufacturing.
• Ensure accurate, timely maintenance of UDI/GUDID data, licenses, registrations, listings, and post approval commitments.
• Lead the development, interpretation, and continuous improvement of regulatory policies, procedures, and SOPs, in alignment with Regulatory management and applicable document-control processes.
• Monitor, assess, and communicate regulatory changes, translating requirements into actionable guidance for stakeholders.
• Partner with Quality and Operations to support audits, inspections, recalls, and remediation activities, ensuring effective regulatory risk management.
• Provide regulatory review and technical guidance for labeling, promotional materials, and advertising to support compliance with applicable regulations.
• Act as a strategic regulatory partner to R&D, Quality, Clinical, Manufacturing, Marketing, and Supply Chain teams.
• Mentor and coach regulatory team members and cross-functional partners, strengthening overall regulatory capability within the organization.
• Deliver training and education on regulatory requirements, trends, and best practices to promote an enterprise-wide compliance culture.
• Collaborate with external consultants, notified bodies, and legal counsel to resolve complex regulatory challenges.
• Ensure timely execution and completion of regulatory activities to support product launch timelines and business milestones.
• Maintain accurate, compliant regulatory documentation and systems.
• Uphold the highest ethical standards, confidentiality, and integrity in all regulatory interactions.
• Perform other duties as required to support the regulatory function and business objectives.

Qualifications
Required
• Bachelor’s degree or equivalent combination of education and experience.
• Minimum of 7 years of medical device regulatory affairs experience, including at least 2 years hands-on experience with FDA submissions (510(k), PMA, IDE) for Class II and/or Class III devices.
• Demonstrated experience developing regulatory strategies and leading execution of complex submissions and product lifecycle activities.

Preferred
• Regulatory affairs certification.
• Experience with electrical-mechanical devices (IEC 60601).
• Experience with software as a medical device and/or software in a medical device (IEC 62304).

Knowledge & Skills
• Excellent working knowledge of FDA Code of Federal Regulations (21CFR), ISO 13485, MDD/MDR regulations and relevant regulations, requirements and standards related to medical devices.
• Strong proficiency with Microsoft Office tools including Word, Excel, PowerPoint, Teams or other relevant software.
• Strong verbal, written and presentation skills with the ability to effectively communicate at multiple levels in the organization.
• Possess exceptional written and verbal communication skills in preparing multi-stakeholder documents and presentations (e.g., scientific, clinical/medical, regulatory reviewer).
• Strong knowledge in medical device Design Controls and Risk Management.
• Capable of managing multiple projects and complex timelines in a team environment.
• Cross functional collaboration skills needed to foster alignment.
• Excellent influence and impact skills.
• Strong analytical and critical thinking skills.
• Strong cross-functional skills to foster alignment.