Regulatory Affairs Specialist; Hybrid

Who We Are

Refle Xion is a privately held theranostic oncology company located in Hayward, CA, commercializing SCINTIX biology-guided radiotherapy, a novel therapy that uses a single radiotracer injection to turn cancer cells into real-time biological beacons to guide external-beam radiotherapy. SCINTIX therapy is FDA-cleared for FDG-guided treatment of lung and bone tumors, including metastases. The Refle Xion X2 platform is also cleared for conventional image-guided radiotherapy for solid tumors located anywhere in the body.

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We are seeking a Regulatory Affairs Specialist for a 6-month temporary contract to support regulatory activities for medical devices. This role combines scientific, regulatory, and business knowledge to help ensure products meet applicable regulatory requirements across global markets. The ideal candidate will have experience with medical device regulatory submissions and compliance, and will work closely with R&D, manufacturing, and commercial teams to support ongoing regulatory needs and changing requirements.

Contract Duration: 6 months

• Contribute to the preparation and support of regulatory submissions and filings for U.S. FDA and other global regulatory bodies (e.g., Notified Bodies for CE marking, Health Canada).
• Assess and document product changes for regulatory impact.
• Collect and organize information related to product changes and their impact on global regulatory approvals.
• Support product development teams in implementing international regulatory requirements.
• Assist with maintaining annual licenses, registrations, and regulatory listings to ensure continued compliance.
• Support adverse event reporting to regulatory agencies and internal stakeholders.
• Monitor changes in regulations and standards and communicate impacts to internal teams.
• Maintain and update regulatory affairs procedures using established change control processes.
• Maintain and track applicable external regulatory standards.
• Support continuous improvement of regulatory submission processes.
• Perform other related duties as assigned.

• Hybrid - This position will allow the successful candidate to work on a Hybrid work location schedule. They must be based in the greater SF Bay Area and must be able to commute into the Refle Xion office in Hayward 1-2 days a week

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Approximately two (2) years of experience in medical devices or regulatory affairs.
• Experience with electromechanical and/or software-driven medical devices preferred.
• Familiarity with software development as it relates to regulatory submissions is a plus.
• Strong computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
• Excellent attention to detail, organizational, and documentation skills.
• Strong written and verbal communication skills.
• Ability to work independently as well as collaboratively in a team environment.
• Ability to work on-site in Hayward, CA at least part-time during the contract period.

• The opportunity to work with a passionate, driven team in a start-up environment
• Flexible work location and schedule available for many positions - see above for specific work location for this position
• Competitive compensation
• Medical (both HMO and PPO options) with Health Savings Account (HSA) option
• Paid Company Holidays and Paid Sick Time
• Refle Xion Benefit Hub – Company exclusive discounts and deals on a variety of sites and items
• Weekly catered on-site lunches as well as kitchens filled with a variety of healthy and delicious food and drinks – including an espresso machine and panini stations!
• Employee Events – Variety of Lunch ‘n Learns, Financial Wellness education, Regular “Coffee Chats” with Executive Leadership, Scavenger Hunts, Company Milestone celebrations and more!
• Electric car charging stations on site

The pay range for this role is $60 - $70per hour. Actual compensation packages are based on several factors that are unique…