Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist
Tiposi

Tiposi is developing Dragonfly, a portable microwave-based brain scanner for rapid stroke detection at the point of care. We're looking for a Senior Regulatory Affairs Specialist to own our global regulatory strategy and drive Dragonfly through FDA clearance and international market authorization.

This is a high-impact, high-ownership role on a lean team. You'll be the subject matter expert for regulatory affairs, working directly with engineering, clinical, and quality colleagues to move fast without cutting corners.

• Develop and execute regulatory strategies across global markets for Dragonfly and future products, including FDA (510(k), De Novo, PMA, BDD/Q-Sub) and EU MDR pathways
• Lead preparation and submission of regulatory filings, including IDEs, technical files for CE marking, and international registrations
• Serve as primary point of contact with FDA and Notified Bodies; manage meeting preparation, pre-submission interactions, and agency correspondence
• Draft clear, persuasive responses to deficiency letters and requests for additional information under tight deadlines
• Own and maintain risk management files per ISO 14971 and usability/human factors documentation per IEC 62366
• Generate GSPRs, Essential Requirements checklists, and Declarations of Conformity as needed
• Track and interpret evolving global medical device regulations and translate them into actionable guidance for the team
• Shape and maintain the regulatory components of Tiposi's QMS in alignment with ISO 13485, MDR 2017/745, and FDA QSR
• Support design controls and design reviews as the regulatory SME from concept through commercialization
• Manage device registrations, authorizations, and certificates across jurisdictions
• Build templates, tools, and training materials to scale regulatory knowledge internally
• Support clinical trial regulatory activities including authority notifications and approvals
• Contribute to internal audits and regulatory inspections

• Engineering degree or equivalent in life sciences, regulatory affairs, or a related field
• 5+ years of progressive regulatory affairs experience in medical devices
• Demonstrated expertise with FDA submissions (510(k), De Novo, PMA, Q-Subs) and EU MDR
• Experience preparing for and conducting regulatory meetings (Pre-Subs, etc.)
• Strong working knowledge of global medical device regulatory frameworks
• Experience with Class II–III devices; combination products or biologics a plus
• Track record developing regulatory strategies for novel or first‑in‑class technologies
• Excellent project management skills; comfortable managing multiple complex work streams simultaneously
• Strong interpersonal and communication skills; able to work cross‑functionally and across cultures
• Detail‑oriented with solid analytical and problem‑solving instincts
• Ability to travel domestically and internationally as needed

• Experience with neurological devices or active implantable/non-implantable devices
• Familiarity with Breakthrough Device Designation process
• Knowledge of biologics regulations (BLA/IND) for combination products
• MDSAP or ISO 13485 certification experience
• RAC certification or advanced degree in regulatory science
• Prior startup or fast‑paced environment experience
• Proficiency with electronic QMS, PLM, or project management tools (e.g., Asana)

Offer within range is determined by experience, skills, and interview performance. Equity is not reflected in the base range.

• Medical, dental, vision, and life insurance
• Paid parental, medical, and family care leave
• FSA / Dependent Care FSA
• 401(k)
• Paid meals

Tiposi is an equal opportunity employer. We are committed to building an inclusive team and welcome applicants of all backgrounds and identities.