Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist TiposiTiposi 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 doDevelop 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 pathwaysLead preparation and submission of regulatory filings, including IDEs, technical files for CE marking, and international registrationsServe as primary point of contact with FDA and Notified Bodies; manage meeting preparation, pre-submission interactions, and agency correspondenceDraft clear, persuasive responses to deficiency letters and requests for additional information under tight deadlinesOwn and maintain risk management files per ISO 14971 and usability/human factors documentation per IEC 62366Generate GSPRs, Essential Requirements checklists, and Declarations of Conformity as neededTrack and interpret evolving global medical device regulations and translate them into actionable guidance for the teamShape and maintain the regulatory components of Tiposi's QMS in alignment with ISO 13485, MDR 2017/745, and FDA QSRSupport design controls and design reviews as the regulatory SME from concept through commercializationManage device registrations, authorizations, and certificates across jurisdictionsBuild templates, tools, and training materials to scale regulatory knowledge internallySupport clinical trial regulatory activities including authority notifications and approvalsContribute to internal audits and regulatory inspectionsWhat you bringEngineering degree or equivalent in life sciences, regulatory affairs, or a related field5+ years of progressive regulatory affairs experience in medical devicesDemonstrated expertise with FDA submissions (510(k), De Novo, PMA, Q-Subs) and EU MDRExperience preparing for and conducting regulatory meetings (Pre-Subs, etc.)Strong working knowledge of global medical device regulatory frameworksExperience with Class II–III devices; combination products or biologics a plusTrack record developing regulatory strategies for novel or first-in-class technologiesExcellent project management skills; comfortable managing multiple complex workstreams simultaneouslyStrong interpersonal and communication skills; able to work cross-functionally and across culturesDetail-oriented with solid analytical and problem-solving instinctsAbility to travel domestically and internationally as neededNice to haveExperience with neurological devices or active implantable/non-implantable devicesFamiliarity with Breakthrough Device Designation processKnowledge of biologics regulations (BLA/IND) for combination productsMDSAP or ISO 13485 certification experienceRAC certification or advanced degree in regulatory sciencePrior startup or fast-paced environment experienceProficiency with electronic QMS, PLM, or project management tools (e.g., Asana)CompensationOffer within range is determined by experience, skills, and interview performance. Equity is not reflected in the base range.BenefitsMedical, dental, vision, and life insurancePaid parental, medical, and family care leaveFSA / Dependent Care FSA401(k)Paid mealsTiposi is an equal opportunity employer. We are committed to building an inclusive team and welcome applicants of all backgrounds and identities.