Job Description
About CardioMed:
CardioMed Device Consultants is expanding and seeking an experienced Principal Consultant to serve as a strategic partner to companies developing novel Class II and Class III implantable and interventional medical devices, including digital health technologies.
This role is ideal for a senior regulatory professional with deep FDA experience who enjoys working closely with innovative medical device companies as a trusted regulatory advisor, while also contributing to client development and growth of long-term partnerships.
The Principal Consultant supports U.S. regulatory programs across the full product lifecycle-including early development, clinical investigations, marketing applications, and post-market activities-and collaborates with sponsor leadership to shape regulatory strategy, support FDA interactions, and expand client relationships.
- CardioMed Device Consultants is a specialized medical device regulatory consulting firm known for:
- Technical rigor in preclinical testing and regulatory strategy
- Thoughtful, effective FDA interactions
- Long-term partnerships with medical device innovators
Our team includes former FDA reviewers, engineers, clinicians, scientists, and regulatory strategists with extensive experience supporting Class II and Class III medical devices, including Pre-Submissions, IDEs, 510(k)s, PMAs, HDEs, and post-market programs.
Role Overview
As a Principal Consultant, you will provide strategic regulatory guidance and preclinical testing support to medical device manufacturers, working directly with sponsor leadership and cross-functional teams. You will play a key role in shaping regulatory pathways, preclinical testing strategies, contributing to FDA submissions, and supporting FDA interactions for complex and novel technologies.
- Key Qualifications
- Professional Experience: Strongly preferred 4–5 years of experience at the U.S. Food and Drug Administration (FDA) or equivalent senior-level experience in medical device regulatory affairs.
- Strategic Leadership: Demonstrated ability to lead Q-Submissions and support FDA review of complex preclinical safety programs and clinical trial designs.
- Subject Matter Expertise: Demonstrated technical expertise in Class II and Class III medical device standards, with subject matter expertise in at least one preclinical testing area (e.g., biocompatibility, in vivo studies, software verification and validation etc.). Familiarity with Software as a Medical Device (SaMD), including cybersecurity and AI/ML considerations, is a plus.
- Analytical Writing: Strong technical writing skills, with the ability to translate complex clinical and preclinical data into clear, persuasive regulatory narratives for IDEs and marketing applications.
- Quality Systems Knowledge: Working knowledge of 21 CFR Part 820 (Quality System Regulation) and ISO 13485, with the ability to align design controls with regulatory submissions.
- Communication: Demonstrated ability to clearly communicate complex regulatory issues and risk to senior and executive stakeholders.
- Global Awareness: Broad understanding of global regulatory environments-particularly EU and Japan-to support client global launch strategies beyond the U.S. market.
- Key Responsibilities
- Strategic Planning: Develop comprehensive regulatory strategies to support the development and market entry of novel Class II and Class III implantable, interventional, and digital health devices.
- FDA Submissions: Lead or substantially contribute to the preparation, authoring, and review of FDA regulatory submissions, including Pre-Submissions, IDEs, 510(k)s, PMAs, and De Novo applications.
- Agency Interaction: Serve as a primary liaison with the FDA's Center for Devices and Radiological Health (CDRH); coordinate and participate in Pre-Submission meetings and other formal FDA interactions on behalf of CardioMed clients.
- Lifecycle Management: Provide regulatory and preclinical testing guidance across the full product lifecycle, from early design considerations and feasibility assessments through post-market compliance and reporting.
- Technical Writing & Review: Draft and critically review technical documents, white papers, manuscripts, and device labeling/Instructions for Use (IFU) to ensure scientific accuracy and regulatory compliance.
- Compliance Interpretation: Interpret complex medical device regulations and evolving FDA guidance to identify efficient and appropriate regulatory pathways for emerging and breakthrough technologies.
- Regulatory Intelligence: Monitor and advise on changes in U.S. and global regulatory landscapes relevant to CardioMed clients.
- Client Collaboration: Conduct regulatory due diligence and collaborate with cross-functional teams to integrate regulatory requirements into early-stage product development for startup, mid-size, and large medical device manufacturers.
- Business Development: Contribute to business development efforts by supporting client engagements, identifying opportunities for expanded regulatory support, and helping build long-term client relationships.
- Public Speaking: Represent CardioMed as a speaker or panelist at industry conferences such as Transcatheter Cardiovascular Therapeutics (TCT), EuroPCR, Cardiovascular Research Technologies (CRT), and other relevant medical device forums.
- Educational Programming: Design and deliver customized regulatory and preclinical testing training workshops for medical device manufacturers, with emphasis on FDA submission strategy and evolving FDA guidance, ASTM, AAMI, and ISO standards.
- Industry Engagement: Actively participate in professional societies (e.g., RAPS, AdvaMed) to remain current on policy developments and contribute to discussions on regulatory pathways for novel technologies.
- Mentorship & Knowledge Sharing: Mentor junior consultants and translate regulatory feedback into shared lessons that strengthens the expertise of the CardioMed team
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