Position Overview

The Regulatory Affairs Specialist will be responsible for supporting the preparation, review and submission of technical documentation for US and international product approvals.

Responsibilities include developing and executing on strategies to ensure applicable regulatory requirements are met for new and modified medical devices.

This role operates in a supporting role, working proactively and collaboratively with cross-functional team members to meet ambitious project objectives and drive successful regulatory outcomes. Sustaining regulatory responsibilities include review of changes to products and labeling to ensure that market-specific regulatory requirements continue to be met, documenting “letter to file” decisions, and ensuring that Outset’s product technical documentation remains current and accurate.  

Essential Job Functions and Responsibilities

• 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.

Minimum Qualifications

• 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%).

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)

The Annual Salary Range for this role will be: $90,000-140,000.

We feel passionately about pay equality.  Discretionary adjustments to the position’s starting compensation may be made in consideration of other relevant factors pertaining to eligible applicants, including, but not limited to, their specific skills, level, geographical location, and comparison to other employees already in the same or similar roles.

*This range represents our good-faith and reasonable estimate regarding what we reasonably expect to pay for this position at the time of posting. 

Outset also offers the following benefits:

• Medical 
• Dental
• Vision
• EAP/Mental Health
• Life Insurance/AD&D
• Short/Long Term Disability
• FSA (Dependent & Healthcare)
• HSA w/ Employer contribution
• Commuter Benefits
• 401K w/ company match
• ESPP
• Fertility benefits
• Wellness initiatives
• Legal Assistance
• Pet insurance
• Financial Advisement & Wellbeing
• Tuition Reimbursement
• Student Loan Payback
• Employee discounts
• Professional Development/Learning
• Collaboration Days (lunch onsite)
• Happy Hours/Karaoke
• PTO/Sick time
• Holidays + Volunteer Day