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Regulatory Affairs Specialist
Confirmed live in the last 24 hours
San Jose, CA, USA
Experience Level
  • Minimum Experience: 3 years of US and International medical device, IVD or pharmaceutical regulatory submission/approval experience (g. US FDA, EU MDD/AIMD, EU MDR, Japan PMDA, Australia TGA, Saudi FDA, China NMPA, etc.); or 1 year of experience with relevant advanced degree
  • BS in Scientific, Engineering or equivalent discipline with 3 years minimum experience in biotechnology, medical device registrations, compliance and/or quality systems
  • Working knowledge and experience with FDA and international regulations, guidance documents, global regulatory requirements and international safety, performance and quality standards
  • Experience with medical device design, development, and manufacturing regulations, including 21 CFR Part 820 Quality System Regulation, ISO 13485, ISO 14971 requirements
  • Ability to work effectively in a fast paced and dynamic environment
  • Organized and logical; able to prioritize and handle several projects concurrently
  • Able to follow instructions and work on a mostly independent basis
  • Proven analytical abilities
  • Demonstrated interest in staying current on regulatory trends
  • Strong verbal and written command of the English language
  • Must be able to understand, describe and summarize laboratory and clinical data
  • Able to understand, communicate and present technical information in a logical manner such that it can be understood by a layman
  • Must be able to operate computer and office equipment as needed
  • Work Location: Remote, with travel to Outset Medical Headquarters in San Jose, CA on a quarterly basis and/or as needed. Additional global travel may be required to perform job functions (≤25%)
  • Compiles and reviews materials required to implement regulatory strategies for new technologies and product modifications, considering both domestic and international regulations
  • Remain organized and logical; able to prioritize and handle several projects concurrently to meet project deadlines and organizational objectives
  • Actively use strong critical thinking skills to navigate complex regulatory situations, reaching and applying appropriate, defensible conclusions
  • Use excellent written, verbal and interpersonal communication skills to clearly convey information and requirements to internal and external stakeholders
  • Work under general direction to support project teams with regulatory deliverables, providing input and guidance to project teams on pre-market regulatory requirements, documentation, testing, labeling and clinical compliance issues
  • Collaborate closely with R&D Engineering, Clinical, Risk, Quality, Human Factors, Marketing, Supply Chain and other cross-functional personnel, as needed, to solve challenges and meet project goals
  • Establish and maintain a professional relationship with regulatory agencies including the FDA, notified bodies, and other regulatory organizations while maintaining confidentiality with company documentation and discussions
  • Possess strong attention to detail with the ability to identify and articulate quality and compliance related risks and potential impacts to key stakeholders
  • Actively develop and execute strategies for responses to FDA, Notified Body, and government agency questions with cross-functional team, establishing and maintaining a professional rapport while navigating to successful outcomes
  • Maintain annual licenses, registrations and listings
  • May assist with review and approval of marketing, advertising and promotional collateral as well as review of regulatory aspects of contracts
  • Creatively identify risk-based solutions and implement strategic solutions
  • Participate in and support internal and external compliance audits
Desired Qualifications
  • Regulatory submission experience (e.g. Premarket Notification 510(k), PMA, De Novo, MDD 93/42/EEC, EU MDR 2017/745)
  • Advanced degree in Scientific, Engineering or equivalent discipline (preferred)
  • Demonstrated project management experience (preferred)
  • Knowledge of product life-cycle management including development process, design and change control through device life-time
  • Familiarity with software development and documentation
  • Familiarity with ISO 10993 and IEC 60601 series standards (preferred)
  • Regulatory Affairs Certification (RAC) (preferred)
Outset Medical

501-1,000 employees

Dialysis medial equipment manufacturer
Company Overview
Outset Medical is on a mission to transform the dialysis experience – one of the largest, most expensive, and stagnant areas of healthcare. The company is focused on creating change, driving widespread adoption of new technology, and delivering on the promise of an improved experience for patients and lower cost of care for healthcare providers.
  • Medical, dental, & vision
  • Life Insurance/AD&D
  • FSA & HSA
  • 401k
  • Parental leave
  • Pet insurance
  • Tuition reimbursement
  • PTO
  • Company events
Company Core Values
  • Farther
  • Faster
  • Together