The Principal Regulatory Affairs Specialist will serve as a key contributor responsible for authoring and compiling regulatory submissions, providing regulatory guidance to cross-functional teams, conducting regulatory intelligence activities, and supporting post-market compliance through complaint and Medical Device Reporting (MDR) assessments.
The ideal candidate is a highly skilled individual with extensive experience developing regulatory submissions and translating complex technical information into clear, compliant regulatory documentation. This individual will be a regulatory subject matter expert who thrives in a fast-paced startup environment, consistently delivers high-quality work products, and drives activities to completion while managing multiple priorities and timelines.
Responsibilities
• Lead the planning, development, authoring, compilation, submission, execution and maintenance of regulatory submissions, including 510(k)s, IDEs, IDE supplements, Pre-Submissions (Q-Subs), and international submissions, as applicable ensuring alignment with overall regulatory strategy
• Drive regulatory deliverables to completion while proactively identifying and mitigating regulatory risks, identifying dependencies and potential impact to project timelines and objectives.
• Ensure submissions are scientifically sound, technically accurate, well organized, and compliant with applicable regulations, standards, and guidance documents.
• Support regulatory agency interactions through preparation of briefing materials, response packages, and meeting preparation and documentation of Agency feedback and commitments.
• Coordinate and project manage regulatory submission activities across functions in Engineering, Quality, Clinical, Operations, and Program Management teams to establish timelines based on the deliverables and dependencies to ensure complete, consistent, and timely regulatory submissions.
• Serve as a regulatory SME for product development teams by Interpreting FDA regulations, guidance documents, consensus standards and industry best practices and communicate requirements to stakeholders across the organization.
• Provide regulatory support throughout the product development life cycle including design controls, risk management, verification and validation, and product claims to ensure alignment with regulatory requirements and the strategy.
• Assess and document the regulatory impact of product changes, design modifications, and development decisions and provide recommendations on appropriate regulatory pathway and submission requirements to the teams.
• Conduct regulatory intelligence research involving regulations, guidance documents, consensus standards, enforcement trends, and industry developments. Analyze post-market data sources, including adverse event databases, recalls, safety communications, competitor activity, and published literature to support regulatory decision-making.
• Serve as the regulatory representative supporting complaint handling and post-market surveillance activities. Collaborate with Quality, Clinical, and Engineering teams to evaluate complaints, adverse events, and potential reportable incidents.
• Support preparation, review, and submission of MDRs and identify trends that may require regulatory escalation or corrective action.
• Support review of product claims and labeling for intended, indications for use and specifications from regulatory perspective.
Requirements
Required Skills & Abilities
• Deep knowledge of FDA medical device regulations (21 CFR 820 (QMSR), applicable FDA guidance documents, consensus standards, ISO 13485 and ISO 14971 principles.
• Strong knowledge of EU and OUS medical device regulatory frameworks.
• Expert-level technical writing and submission authoring skills.
• Strong understanding of medical device product development processes.
• Ability to analyze complex technical data and present regulatory conclusions effectively.
• Demonstrated ability to independently drive projects from concept through submission and clearance.
• Strong ability to manage multiple priorities concurrently, track milestones, and consistently deliver high-quality work with minimal supervision.
• Strong interpersonal skills and ability to influence and collaborate effectively across all levels of the organization.
• Expertise in Microsoft Office and Adobe Acrobat applications
Education & Experience
• Bachelor's degree in Engineering, Biology, Life Sciences, or a related technical discipline with 7-11+ years of medical device regulatory affairs experience; or a Master's degree in a related discipline with 5-7+ years of medical device regulatory affairs experience.
• Certification in regulatory affairs (RAC) preferred
• Demonstrated experience preparing and authoring successful FDA submissions, including 510(k), IDE, and/or Pre-Submissions.
• Experience working in early-stage, startup, or pre-commercial medical device environments preferred.
• Dialysis or renal medical device experience preferred.
Travel
• Ability to travel (domestic and international) as required
Physical Requirements
• Prolonged periods of sitting at a desk and working on a computer
• May be expected to lift 15 pounds at times
Working Environment:
• Office or work-station environment
Salary Description
$127,000 - $153,000
