Job Overview
We are seeking a dynamic and detail-oriented Regulatory Affairs Specialist specializing in Drug and Device Combination Products to join our innovative team. In this pivotal role, you will navigate the complex landscape of regulatory requirements to ensure our combination products - integrating pharmaceuticals, medical devices, and biologics—meet all safety, efficacy, and compliance standards.
Note: You will be responsible for developing and executing regulatory strategies for combination products with a primary focus on U.S. FDA 510(k) submissions. This role will lead the preparation, review, submission, and defense of major 510(k) dossiers, ensuring compliance with applicable regulations and alignment with business objectives. The specialist will serve as a key cross-functional partner, guiding product development teams through regulatory requirements from concept through commercialization.
Key Responsibilities
Regulatory Strategy & Planning
• Develop and implement regulatory strategies for combination products (drug-device, biologic-device, or device-led products).
• Determine appropriate regulatory pathways, with emphasis on 510(k), Special 510(k), and Traditional 510(k) submissions.
• Provide regulatory guidance during product development, design control, and change management processes.
• Interpret and apply FDA regulations, guidance documents, and standards relevant to combination products.
• Develop and implement regulatory strategies for combination products across all lifecycle stages.
• Interpret and apply global regulations, guidance, and standards related to combination products (e.g., 21 CFR Part 3, Part 4).
• Provide regulatory input to cross-functional teams (R&D, Quality, Clinical, Manufacturing).
• Determine regulatory pathways (e.g., NDA, BLA, 510(k), PMA, IND/IDE combinations).
Submission Preparation & Management
• Lead the end-to-end preparation of major 510(k) submissions, including:
• Device description and classification
• Substantial equivalence comparisons
• Labeling and Instructions for Use (IFU)
• Performance testing (bench, software, biocompatibility, sterility, etc.)
• Compile, author, and review technical documentation ensuring completeness, accuracy, and compliance.
• Coordinate with cross-functional teams (R&D, Quality, Clinical, Manufacturing) to gather required data and documentation.
• Ensure submissions meet FDA formatting and eCopy requirements.
• INDs, NDAs, BLAs, IDEs
• 510(k), PMA, De Novo submissions
• Technical documentation for EU MDR
• Ensure high-quality documentation that meets global regulatory standards (e.g., CTD/eCTD format).
• Manage submission timelines and coordinate cross-functional contributions.
• Maintain submission readiness and document control systems.
Regulatory Review & Defense
• Serve as the primary point of contact with FDA for 510(k) submissions.
• Prepare and manage responses to FDA requests, including Additional Information (AI) letters.
• Lead internal review meetings and readiness assessments prior to submission.
• Defend regulatory strategies and submission content during FDA interactions and audits.
• Review technical, clinical, and quality documentation for regulatory compliance: ISO 13485, ISO 14971, ICH guidelines
• Support design control and risk management activities specific to combination products.
• Ensure compliance with both drug (CDER/CBER) and device (CDRH) regulatory frameworks.
• Serve as primary contact with regulatory authorities including the U.S. Food and Drug Administration, European Medicines Agency, and other global agencies.
• Prepare briefing packages and lead regulatory meetings (Pre-IND, Type B/C, scientific advice).
• Respond to agency questions, deficiency letters, and requests for information.
• Defend regulatory strategies and submission content during audits and inspections.
Combination Product Compliance
• Ensure compliance with combination product regulations (21 CFR Part 3, Part 4).
• Coordinate integration of device and drug/biologic regulatory requirements, including cGMP alignment.
• Support human factors, risk management, and usability engineering activities specific to combination products.
Cross-Functional Collaboration
• Partner with Quality Assurance on design controls, risk management (ISO 14971), and QMS compliance.
• Collaborate with Clinical Affairs on clinical strategy, if required for 510(k) or De Novo pathways.
• Work with labeling, marketing, and medical teams to ensure regulatory-compliant claims and materials.
Lifecycle Management
• Assess regulatory impact of design changes and determine need for new or modified submissions.
• Support post-market activities including complaint investigations, adverse event reporting, and field actions.
• Maintain regulatory files and ensure inspection readiness.
QualificationsEducation
• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related field required
• Advanced degree (MS, MPH, RAC) preferred
Experience
• 4–8+ years of regulatory affairs experience in medical devices or combination products
• Demonstrated experience leading and authoring successful 510(k) submissions (major submissions required)
• Experience with combination products strongly preferred
Knowledge & Skills
• In-depth knowledge of FDA regulations and guidance for medical devices and combination products
• Strong understanding of:
• 21 CFR Parts 807, 820, and 4
• Design controls and risk management
• Usability/human factors engineering
• Proven ability to prepare, review, and defend regulatory submissions
• Excellent technical writing and document review skills
• Strong project management and organizational abilities
• Effective communication skills for interfacing with regulatory authorities and internal stakeholders
Pay: $35.00 - $65.00 per hour
Work Location: Remote