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. What you'll do 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 What you bring 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 workstreams 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 Nice to have 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) Compensation 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. #J-18808-Ljbffr Tiposi