Principal Regulatory Affairs Specialist - Mondo : Job Details

About the Role:

We're looking for a detail-oriented and proactive Principal Regulatory Affairs Specialist to join our growing team. In this highly cross-functional role, you will lead regulatory strategy and documentation efforts for complex diagnostic instruments nearing global launch. You'll be instrumental in securing regulatory approvals across multiple markets, including the U.S., EU, and Canada.

This is a high-impact opportunity to contribute to a five-year flagship project entering its final stretch. You will bring nuance, attention to detail, and flexible problem-solving to ensure regulatory approvals stay on track across changing priorities and evolving requirements.

What You'll Do:

• Lead the preparation, review, and authorship of key regulatory submissions such as 510(k)s, BLAs, PAS, and CBE-30s.
• Interpret and apply global regulatory requirements (U.S. FDA, EU IVDR, Health Canada) for new and existing products.
• Collaborate cross-functionally with R&D, Quality, Clinical, and Manufacturing teams to gather required technical documentation.
• Ensure alignment of submission strategies with regulatory expectations and evolving standards.
• Write and review regulatory documentation, technical reports, and summaries (note: you'll review technical content, not generate it).
• Support post-market regulatory activities, including labeling updates, product changes, and surveillance documentation.
• Contribute to internal training and process development for regulatory systems (eSTAR, QMS, etc.).
• Act as a regulatory liaison in cross-functional meetings, proactively addressing gaps or risks in submission readiness.

Must-Have Qualifications:

• 5+ years of professional experience, including 3+ years in regulatory affairs (background in quality is acceptable with strong regulatory exposure).
• Experience with FDA submissions including 510(k) preparation (at least 5–10 submissions preferred); eSTAR system familiarity is a plus.
• Experience with IVD (in vitro diagnostics) preferred; medical device experience acceptable.
• Strong knowledge of QMS (Quality Management Systems) and post-market surveillance requirements.
• Experience working within technical documentation frameworks.
• Solid understanding of global regulatory bodies with preference for U.S. FDA experience; EU IVDR and Health Canada knowledge a plus.
• Excellent written and verbal communication skills—must be comfortable writing reports and speaking up in meetings.
• Bachelor's degree minimum in Human or Physical Sciences; Master's degree preferred.
• Self-starter with strong organizational skills and a collaborative, confident approach to problem-solving.
• Comfortable navigating ambiguity and frequent changes; thrives in fast-paced environments.

Nice to Haves:

• IVD product or blood banking experience
• Regulatory support for labeling activities
• Prior experience in small team project management
• Military background or military family connection—valued for adaptability and team discipline
• Experience working in fast-growing or matrixed regulatory teams

Benefits:

• Medical, Dental, Vision, HSA/FSA, Life & Disability, EAP, Pet Insurance, 401k