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Form of workJob Description
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.
Stay up to date with RefleXion by following our channels here:
LinkedIn, X (formerly Twitter),Instagram, Facebook, and YouTube.
About This Role
The (Sr.) Manager of Regulatory Affairs will play a central role in RefleXion's efforts to drive successful market access for RefleXion's medical devices and related products. This leader combines the knowledge of scientific, regulatory, and business issues to enable products that are developed to comply with required regulatory requirements. The (Sr.) Manager of Regulatory Affairs will identify information needed, obtain supporting data and ensure that the information is effectively presented for the registration of products worldwide.
The (Sr.) Manager of Regulatory Affairs will also provide direction and guidance to R&D, operations, and relevant cross-functional teams regarding changing regulatory requirements and standards.
What You Will Be Doing
- Manage Regulatory Intelligence efforts
- Assist 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
- Manage regulatory submission logistics
- Develop the standards compliance strategy for Company products and support activities required to maintain regulatory compliance as new or revised versions of standards are released
- Monitor impact of changing regulations on submission strategies and regulatory compliance requirements
- 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
- 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 2-4 days a week, depending on the role
What We Need
- Bachelor's degree in a scientific or engineering discipline or a commensurate professional experience working on technical products / medical devices
- 5 or more years' professional experience working in medical device Regulatory Affairs for devices
- Familiarity with design controls, test methods and standards for the design, verification, and validation of medical device products required
- Experience participating in meetings with regulatory agencies, including submitting relevant documents
- Experience with medical device software products for both pre-and-post market
- Must have prior working experience with application processes for 510(k)s, Health Canada Applications or CE Mark applications and technical files
- Experience with the development, writing and submittal of successful 510(k)/PMA/De Novo submissions
- Strong project management, planning and change management skills
- Reliable, self-motivated, with leadership experience
- Strong ability to work across organizational boundaries
- Experience leading post-market activities such as licenses and registrations; MDR reporting decisions
- Excellent verbal (including presentation) and written communication skills, especially technical report writing, required
- Excellent computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
- Excellent attention to detail, organizational and negotiation skills
Ways To Stand Out
- Advanced degree in Regulatory Compliance, Engineering, or related discipline
- RAC (Regulatory Affairs Certificate) a strong preference
- 5 or more years' professional experience in regulated Regulatory Affairs for electromechanical or complex software-driven medical devices
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 $120,000 - $180,000 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.
