Hybrid Regulatory Affairs Specialist – 6 Month Contract

at RefleXion Medical

• Job title: Regulatory Affairs Specialist – 6 Month Contract
• Job type: Contract
• Experience level: Junior, Mid level
• Salary: $60 - $70 per hour
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Hayward, United States

About the role

• Regulatory Affairs Specialist supporting regulatory activities for medical devices at RefleXion. Collaborating with teams to ensure products meet global regulatory requirements and compliance.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• Health insurance (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