Job Title: Regulatory Affairs Specialist Date: October 21, 2026

Department: Clinical & Regulatory Location: Remote

 

Virtual Incision is advancing robotic-assisted surgery with a focus on expanding access to minimally invasive care. We are a growing medical technology company where experienced leaders have the opportunity to make a meaningful and visible impact.

Why Virtual Incision:

• Work on innovative robotic surgical technology with the potential to improve patient care.
• Join an experienced, collaborative team focused on clinical excellence and disciplined execution.
• Take meaningful ownership of products and programs in a hands-on environment.
• Work in a culture that values technical rigor, practical problem-solving, and teamwork.
• Competitive benefits including medical, dental, vision, disability, and life insurance, 401(k), flexible working hours, and PTO.

Job Summary:

The Regulatory Affairs Specialist supports the development and execution of regulatory strategies for Virtual Incision's products in both U.S. and international markets. This role works closely with cross-functional teams to ensure regulatory requirements are integrated throughout product development and commercialization activities.

The successful candidate will support regulatory submissions, technical documentation, product changes, labeling reviews, regulatory compliance initiatives, and interactions with regulatory agencies and notified bodies. This individual will help ensure that regulatory objectives, timelines, and requirements are effectively communicated and executed to support continued company growth and market expansion.

Responsibilities:

• Participate on cross-functional product development teams and communicate regulatory requirements, submission deliverables, timelines, and risks.
• Support the development and implementation of regulatory strategies for U.S. and international markets.
• Assist in the preparation, submission, and maintenance of U.S. regulatory submissions, including 510(k) Premarket Notifications, FDA Pre-Submissions, and Investigational Device Exemption (IDE) applications.
• Support the preparation, maintenance, and updating of EU Medical Device Regulation (MDR) technical documentation.
• Collaborate with Engineering, Quality, Clinical, and Marketing teams to ensure products are developed and maintained in accordance with applicable regulatory requirements.
• Support regulatory inspections, audits, and notified body assessments by organizing documentation and assisting with responses and follow-up activities.
• Review device labeling, marketing materials, and promotional content for regulatory compliance and recommend necessary changes.
• Assess the regulatory impact of design, software, manufacturing, labeling, and process changes and document recommendations regarding regulatory submissions or notifications.
• Monitor changes in applicable regulations, guidance documents, standards, and industry trends and communicate potential impacts to the organization.
• Support implementation of regulatory changes resulting from new or revised requirements.
• Contribute to the development and maintenance of regulatory procedures and internal processes.
• Maintain regulatory records and documentation in accordance with company procedures and applicable regulations.
• Support product launch and commercialization activities from a regulatory perspective.
• Participate in continuous improvement initiatives that enhance regulatory compliance and operational effectiveness.
• Perform other duties as assigned.

Qualifications:

Required

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum of three years of regulatory affairs experience within the medical device industry.
• Experience supporting FDA regulatory submissions and interactions, including 510(k), De Novo, and IDE pathways.
• Experience supporting EU MDR technical documentation and notified body interactions.
• Working knowledge of U.S. and European medical device regulations and standards, including: 
  • 21 CFR Part 820
  • EU Medical Device Regulation (MDR)
  • ISO 13485
  • ISO 14971
• Ability to interpret regulatory requirements and translate them into clear, practical guidance for project teams.
• Strong technical writing, documentation, and communication skills.
• Excellent attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Ability to work independently and collaboratively within cross-functional teams.
• Demonstrated sound judgment, professionalism, and ability to maintain confidential information.

Preferred

• Master's degree in Engineering, Regulatory Affairs, Life Sciences, or a related field.
• Regulatory Affairs Certification (RAC) or Regulatory Compliance Certification (RCC).
• Experience with robotic-assisted surgical systems, laparoscopic devices, or other complex medical technologies.
• Experience in a startup, high-growth, or rapidly evolving medical device environment.
• Experience supporting international registrations and market expansion activities.

The ideal candidate is a detail-oriented regulatory professional who enjoys collaborating across functions to bring innovative medical technologies to market. You are proactive, organized, and capable of navigating complex regulatory requirements while maintaining a practical, business-focused approach. You thrive in a fast-paced environment and are excited by the opportunity to help shape the future of robotic-assisted surgery.

Salary: DOE

Status: Exempt

Virtual Incision is an Equal Opportunity Employer and values diversity in its workforce.