Director of Regulatory Affairs

Virtual Incision • Lincoln, NE

67d

About The Position

The Director of Regulatory Affairs is responsible for leading and executing Virtual Incision's U.S. and OUS regulatory programs to support the development, launch, and commercialization of the MIRA Surgical System in a dynamic start-up environment. Acting with a high degree of autonomy, this individual will implement regulatory strategies in close collaboration with Clinical and Medical Affairs and under the guidance of the VP of Clinical and Regulatory Affairs. The Director will serve as a key regulatory voice in cross-functional teams, maintain active engagement with the FDA and global authorities, and remain informed of evolving regulatory requirements, industry trends, and competitive developments to proactively guide company strategy.

Requirements

• Bachelor's degree in life sciences, engineering, or related field required; advanced degree preferred.
• 10 years of medical device regulatory experience, with at least 5 years of management experience
• Proven track record of successful FDA interactions and approvals (510(k), De Novo, PMA, IDE)
• Direct experience writing and leading regulatory filing events (e.g. Q‑Submissions, Letters to file, Safety Reporting, IDEs, 510(k), De Novo, CE Mark)
• In-depth knowledge of U.S. medical device regulations, including 21 CFR Part 11, Part 820, QSR, and ISO 13485; familiarity with MDR is a plus
• Strong execution skills and attention to detail
• Strong leadership, communication, and negotiation skills with the ability to influence across all organizational levels.
• Must be able to proactively make recommendations, align key stakeholders, and drive results in fast-paced environment
• Must be able to learn and maintain technical knowledge of Robotic Assisted Surgical procedures, products and activities
• Ability to organize and prioritize workflow to meet established timeframes and budgets
• Ability to exercise independent judgment consistent with VI's mission and values
• Able to work under pressure and travel as needed (maximum 20%)
• Fluent in computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) required

Responsibilities

• Implement regulatory strategies to support the company's business objectives across different indications
• Oversee the preparation, submission, and maintenance of regulatory filings
• Provide regulatory guidance to cross-functional teams (R&D, Clinical, Quality, Marketing, Operations) throughout the product lifecycle
• Monitor and analyze trends (FDA, Industry, Compliance Standards etc.) impacting on the regulatory landscape of Virtual Incision's current and future product pipeline
• Perform gap assessments and recommend compliance strategies to establish and maintain robust regulatory processes and SOPs to ensure ongoing compliance as requirements evolve
• Manage, mentor, and develop team members, fostering a culture of accountability, compliance, and continuous improvement
• Represent the company in interactions with regulatory authorities
• Stay abreast of company portfolio developments, competitor filings, and regulatory shifts to proactively guide decision-making
• Participate in company and industry events such as sales meetings, training programs, trade shows, and other events/duties as requested
• Other duties as assigned

Benefits

• Flexible working hours, including paid vacation and holidays.
• Healthcare programs including medical, dental, vision, disability, and life insurance.
• 410(k) retirement plan

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Miscellaneous Manufacturing
• Number of Employees: 51-100 employees