Principal Regulatory Affairs Specialist - HYBRID

Who We Are

RefleXion elevates radiopharmaceuticals from drugs that help identify cancer to guides that actively direct external beam radiotherapy by leveraging tumor biology. Designated an FDA Breakthrough Device for lung tumors, RefleXion's SCINTIX® biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. FDA-cleared SCINTIX therapy automates targeting and motion management for use in FDG-guided treatment of lung and bone tumors that arise from primary lung and bone cancers or are metastases from other primary cancers. In strategic collaborations with industry-leading radiopharmaceutical companies, RefleXion is co-developing and co-commercializing disease-specific radiotracers for treating late-stage cancers.

Find out more about RefleXion and SCINTIX therapy at reflexion.com.

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About This Role 

The Principal Regulatory Affairs Specialist will combine knowledge of scientific, regulatory, and business issues to enable products that are developed to meet required regulatory requirements. The Principal Regulatory Affairs Specialist will identify information needed, obtain supporting data and ensure that the information is effectively presented for the registration of products worldwide.  

The Principal Regulatory Affairs Specialist will also provide effective direction and guidance to R&D, manufacturing, clinical, and marketing/sales regarding changing regulatory requirements and standards.

What You Will Be Doing

• Lead in reviewing, writing and preparing the high-level strategy for regulatory submissions and filings required for U.S. FDA and other regulatory bodies (e.g., Notified Bodies for CE marking, Health Canada Licenses, etc.) as needed
• Evaluate changes to products for impact on global regulatory approvals
• Evaluate and provide input into advertising, promotional and scientific materials
• Supervise efforts to monitor impact of changing regulations on submission strategies and updates internal stakeholders
• Responsible for processes involved with maintaining annual licenses, registrations, listings and ensuring they are up-to-date
• Participate in strategy discussions with other internal functions related to new products (Clinical Affairs, External Innovation, Reimbursement), provide regulatory input into their plans, support with any needed regulatory submissions
• Maintain expertise in domestic and international regulations and standards, with a focus on relevant medical devices
• Research and analyze state of the art regulatory requirements related to software, cybersecurity, and other relevant topics
• Supports product development teams with regards to implementation of international regulatory requirements and standards
• Maintains and updates regulatory affairs procedures
• Helps with continuous improvement of the submission process
• Other duties as assigned

Where You Will Do This Job  

• 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 RefleXion office in Hayward 1-4 days a week, depending on the role.

What We Need

• 5+ years' experience in medical device regulatory affairs with direct project management responsibilities and a PhD in science or engineering similar field - OR -
• 8+ years' experience and a master’s degree - OR -
• 10+ years' experience and a bachelor’s degree required
• Excellent project management, planning and change management skills
• Effective collaboration across organizational boundaries
• Familiarity with test methods and standards for the design, verification, and validation of medical device products is required.
• Experience with medical device software products for both pre-and-post market.
• Experience in the development, writing and submittal of successful 510(k)/PMA/De Novo submissions, including interactions with FDA
• Must have prior working experience with application processes for 510(k)s, Health Canada Applications or CE Mark applications and technical files
• Knowledge of electromechanical medical devices, or complex software-driven medical devices is required
• Excellent attention to detail
• Excellent verbal (including presentation) and written communication skills, especially technical report writing, required
• Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
• Ability to work independently as an individual contributor and in a team environment
• Excellent organizational and negotiation skills

Ways To Stand Out

• Regulatory Affairs Certification (RAC) preferred

  What You Will Love About Working with Us!

• The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
• Flexible work location and schedule available for many positions - see above for specific work location for this position
• Competitive compensation and Pre–IPO stock option packages
• Medical (both HMO and PPO options), Dental and Vision
• Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
• Pre-tax Commuter Benefits
• Employee Assistance Program (EAP)
• 401(k)
• 3 Weeks/Year PTO Accrual rate to start and 12 Paid Company Holidays
• Employer paid Life Insurance, short-term and long-term disability
• RefleXion 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 Workshops, 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 $160,000 - $195,000 annually.  Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

Values and Diversity 

RefleXion is an equal opportunity employer. All aspects of employment including the decision to hire will be based on merit, competence, performance, and business needs. We do not discriminate based on race, color, religion, marital status, age, national origin, ancestry, disability/medical​​​ condition, pregnancy, genetic information, gender, sexual orientation, gender identity or ​expression, veteran status, or any other status protected under federal, state, or local law.