Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory Affairs Specialist

Tiposi

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

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Specialist in Milpitas, CA vacancy
  • $92k - $148.35k

     ...our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category...  ...more at are searching for the best talent for a Senior Regulatory Affairs Specialist. This role will work a Hybrid/Flex schedule with 3 days... 
    Senior
    Full time
    Contract work
    Temporary work
    Local area
    Immediate start
    Flexible hours
    3 days per week

    Johnson & Johnson

    Milpitas, CA
    2 days ago
  •  ...ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? Join us as a Senior Regulatory Affairs Specialist and be at the forefront of regulatory science for medical robotics. Your mission? To support a deep culture of... 
    Senior
    Full time

    PROCEPT BioRobotics

    San Jose, CA
    2 days ago
  •  ...Function of Position This role provides expert support for regulatory project management, strategic submissions, and cross-functional...  ...labeling and documentation. • Mentor and coach regulatory affairs specialists. • Track and report metrics on regulatory timelines and... 
    Senior
    Local area
    Worldwide
    Flexible hours

    Intuitive Surgical

    Sunnyvale, CA
    9 hours ago
  • $90k - $180k

     ...Santa Clara : Building A - SCJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date: 2026-07-17...  ...Opportunity As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to... 
    Senior
    Work experience placement
    Worldwide

    Abbott

    Santa Clara, CA
    3 days ago
  • $145k - $167k

     ...clinically relevant diagnostic imaging. Learn MoreAbout The RoleJob Title: Senior Regulatory Affairs SpecialistLocation:Palo Alto, CA or Guilford, CT (Hybrid, 3 days/week)The Senior Regulatory Affairs Specialist advises regulatory strategy for the company’s devices and ensures... 
    Senior
    Work experience placement
    Work at office
    Worldwide
    Work visa
    Night shift
    Weekend work
    3 days per week

    Hyperfine

    Palo Alto, CA
    1 day ago
  • $90k - $180k

     ...wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.This Senior Regulatory Affairs Specialist position is an on-site opportunity working out of our Santa Clara, or Temecula, CA locations in the Abbott Vascular... 
    Senior
    Worldwide
    Shift work

    Abbott

    Santa Clara, CA
    9 hours ago
  •  ...IntelliPro in Sunnyvale, CA is seeking a Regulatory Affairs Specialist 4 for a 6+ month engagement. You will develop regulatory plans, review design controls, and lead submissions such as US FDA 510(k) and Health Canada filings. The ideal candidate has 8+ years in medical... 
    Senior

    Ipro Networks Pte. Ltd.

    Sunnyvale, CA
    2 days ago
  • Sandisk is seeking a detailed-oriented finance professional for the Corporate FP&A team in Milpitas, California. The role focuses on reviewing expense reports to ensure compliance with company policies, validating business expenses, and identifying exceptions or discrepancies...
    Senior

    Sandisk

    Milpitas, CA
    4 days ago
  •  ...Function of Position: This role provides expert support for regulatory project management, strategic submissions, and cross-...  ...regulatory labeling and documentation. Mentor and coach regulatory affairs specialists. Track and report metrics on regulatory timelines and... 
    Senior
    Local area
    Worldwide
    Flexible hours

    Intuitive

    Sunnyvale, CA
    3 days ago
  • $92.7k - $152.9k

    Job Description Summary Sr. International Regulatory Affairs Specialist to join our Regulatory Affairs team. Responsible for preparing and managing regulatory submissions to support global commercialization of new or modified IVD devices and RUO products. Key Job Responsibilities... 
    Senior
    Work experience placement
    Local area

    infusion.fi

    Milpitas, CA
    2 days ago
  • $97.6k - $137.25k

    Worker Sub-Type:RegularJob Description: This role will report into the Director of Internal Audit and SOX Compliance within the Finance organization and is integral to the company’s financial reporting integrity, risk management strategy, and operational resilience. This...
    Senior
    Full time
    Work at office
    Remote work

    BlackBerry

    San Jose, CA
    1 day ago
  • Category (For Job Seekers)Information TechnologyLocation11201 - PCB San Jose CA USA - San Jose, CA 95131 US13147 - EMS Colorado Springs CO USA - Colorado Springs, CO 80918 US13631 - ISS Austin Texas US - Austin, TX 78754 US15551 - EMS Carrollton TX US - Carrollton, 7500...
    Senior
    Work at office

    Sanmina-SCI

    San Jose, CA
    1 day ago
  • $171k - $231.4k

     ...Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products.The ideal...  ...escalation plan, or experience communicating results to senior leadership- Bachelor’s Degree in Scientific discipline e.g... 
    Senior
    For contractors
    Local area
    Flexible hours

    Amazon

    Sunnyvale, CA
    3 days ago
  •  ...Sr. Regulatory Affairs Specialist We are searching for an experienced regulatory professional to work within the Companion Diagnostics (CDx) team of Dako North America. Reporting to the Sr. Director, Regulatory Affairs (CDx), the successful candidate must have global... 
    Senior

    Direct Staffing Inc

    Santa Clara, CA
    5 days ago
  •  ...opportunities.The Opportunity That Awaits You: The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured by...  ...will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs.The ideal candidate... 
    Full time
    Work at office

    PROCEPT BioRobotics

    San Jose, CA
    3 days ago
  • $100k - $200k

     ...States - California - Santa ClaraJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date: 2026-07-15Abbott is...  ...a highly motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA... 
    For contractors

    Abbott

    Santa Clara, CA
    9 hours ago
  •  ...Job Description Job Description Job Title: Senior Principal Applications Engineer – Mass Spectrometry Location:  Industry: Manufacturing/Industrial/Production/Machinery Salary: To be discussed with Client Position summary: The successful Senior... 
    Senior
    Work experience placement

    Fox Point Recruitment LLc

    Milpitas, CA
    a month ago
  • $117k - $144k

     ...technologists, and business leaders to join us.Job Summary:The FTZ Senior Compliance Analyst will support Super Micro Computer, Inc.’s...  ...role is responsible for coordinating FTZ customs processes, regulatory compliance activities, and operational execution associated with... 
    Senior
    Worldwide

    Super Micro Computer

    San Jose, CA
    2 days ago
  • Defining, implementing and/or maintaining R&D strategy, guidelines, systems and services for VISHAYAligning and ensuring implementation of R&D budgets, monitors R&D programs, and allocates resources.Planning and coordinating, and/or implementing R&D projects and processes...
    Senior
    Full time

    Vishay

    San Jose, CA
    2 days ago
  • PwC is seeking a Senior Associate for SAP Business Process & IT Controls in Palo Alto, California. This role involves optimizing operational...  ...client needs, provide implementation solutions, and support regulatory adherence. The position requires a Bachelor's degree and at... 
    Senior

    PwC

    Palo Alto, CA
    9 hours ago
  •  ...Join a pioneering MedTech company that's transforming cardiac care with innovative solutions. The client seeks a Principal Regulatory Affairs Specialist to lead complex regulatory strategies and submissions for Class III implantable devices and software-driven technologies... 

    Real

    Sunnyvale, CA
    4 days ago
  • $220k - $240k

     ...communication cadences, delivering clear program health updates, managing strategic risks, and escalating change control decisions to senior leadership. Technical Partnership: Collaborate with Engineering Managers and Architects to provide technical oversight on key... 
    Senior

    Saviynt

    Milpitas, CA
    18 days ago
  •  ...Micron Technology, Inc. in San Jose is seeking a Senior / Principal Layout Engineer to drive pathfinding and architecture exploration for next-generation memory modules and form factors. The role focuses on pre-product definition, feasibility studies, and design tradeoff... 
    Senior

    Jobleads-US

    San Jose, CA
    3 days ago
  •  ...Responsibilities Lead the Medical Affairs and Clinical Affairs teams Develop and manage laboratory professionals and Medical Affairs team Oversee clinical project management and execution Collaborate with stakeholders for evidence generation Ensure global... 
    Senior
    Remote work

    Jobtailor

    Milpitas, CA
    3 days ago
  • $81.5k - $141.3k

     ...and software, vessel closure devices and peripheral stents.The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara, CA or Temecula, CA. In this role, you will support EU and US... 
    For contractors
    Shift work

    Abbott

    Santa Clara, CA
    4 days ago
  • $210.16k - $271.98k

    Senior Principal Systems Development EngineerHelp architect and deliver Dell's L11 rack-scale AI solutions: fully integrated racks that bring Dell IP and partner technologies together to fuel our customers' AI growth. As a Principal Systems Development Engineer, you'll... 
    Senior

    Dell Technologies

    Santa Clara, CA
    3 days ago
  •  ...A leading technology company in California is seeking a Senior Director of Sales to drive revenue growth and manage strategic partnerships. The ideal candidate will have at least 15 years of sales experience in the semiconductor industry, with strong leadership and communication... 
    Senior

    Omni Design Technologies Inc

    Milpitas, CA
    1 day ago
  •  ...equivalent practical/military experience ~12+ years of professional software engineering experience, including significant time in senior technical leadership roles ~ Strong proficiency in C and C++ programming languages on Unix-based platforms ~ Solid... 
    Senior

    Jobtailor

    Santa Clara, CA
    4 days ago
  •  ...Applied Signal Technology, a RTX company, seeks a Senior Principal Software Engineer in San Jose, CA, onsite. Lead DSP-focused design and optimization, mentor engineers, and collaborate with project managers on complex signal processing challenges. Requirements include... 
    Senior
    Relocation

    Jobleads-US

    San Jose, CA
    2 days ago
  •  ...Senior Director, Principal Gifts About the Company Philanthropic organization supporting Indigenous culture & individuals Industry Non-Profit Organization Management Type Non Profit Founded 2017 Employees 11-50 Categories ~ Non-Profit &... 
    Senior

    Confidential

    San Jose, CA
    4 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Affairs Specialist. Be the first to apply!