Regulatory Affairs Specialist (Hybrid): 6 Month Contract
About the position
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
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.
• 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.
Nice-to-haves
• Experience with electromechanical and/or software-driven medical devices preferred.
• Familiarity with software development as it relates to regulatory submissions is a plus.
Benefits
• The opportunity to work with a passionate, driven team in a start-up environment
• Flexible work location and schedule available for many positions
• 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
Apply tot his job
Apply To this Job
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
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.
• 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.
Nice-to-haves
• Experience with electromechanical and/or software-driven medical devices preferred.
• Familiarity with software development as it relates to regulatory submissions is a plus.
Benefits
• The opportunity to work with a passionate, driven team in a start-up environment
• Flexible work location and schedule available for many positions
• 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
Apply tot his job
Apply To this Job