Back to jobs

Regulatory Affairs Specialist (Hybrid): 6 Month Contract

Hayward, CA

Who We Are

RefleXion 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 RefleXion X2 platform is also cleared for conventional image-guided radiotherapy for solid tumors located anywhere in the body. 

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

Stay up to date with RefleXion by following our channels here:

LinkedIn, X, Facebook, Instagram, YouTube.

About This Role

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

What You Will Be Doing

  • 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.

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 1-2 days a week

What We Need and Ways to Stand Out

  • 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.

What You Will Love About Working with Us!

  • 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
  • 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 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 - $70 per hour. 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.

 

Create a Job Alert

Interested in building your career at RefleXion Medical? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...
Select...
Have you previously worked for RefleXion? *
What work schedule / location(s) are you open to? Please check all that apply. *
Select...
Select...
If outside the San Francisco Bay Area, are you open to relocation to the SF Bay Area, either now or in the future? Please select all that apply. *

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in RefleXion Medical’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.