Director of Regulatory Affairs

Lincoln, NE
Posted 1 month ago 

Contribute to advancing robotic-assisted surgery while working for a company that respects, values, and appreciates all team members!

Why you will love working at Virtual Incision: 

  • Strong mission to expand access to robotic-assisted surgery, one of the most exciting fields in healthcare today.
  • Company-wide dedication to clinical excellence, innovation, and teamwork
  • Friendly, open, and fun culture where people genuinely like each other
  • Opportunity to take ownership on exciting projects from day one.
  • Career development through fast pace and an all-hands-on-deck culture
  • Mentorship from some of the top industry experts
  • Flexible working hours, including paid vacation and holidays.
  • Healthcare programs including medical, dental, vision, disability, and life insurance.
  • 410(k) retirement plan

Job Summary:

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.

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

Qualifications:

  • 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

Salary: DOE
Status: Exempt

Job Features

Job Category

Clinical and Regulatory Affairs

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Disclosure and Important Safety Information

The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. Patients and doctors should review all available information on nonsurgical and surgical options and associated risks in order to make an informed decision.

Serious complications may occur in any surgery, including minimally invasive surgery with the MIRA Surgical System, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs, and/or conversion to other surgical techniques which could result in a longer operative time and/or complications.

For important safety information, including surgical risks and considerations, please also refer to www.virtualincision.com/safety-information. For the product’s indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s).

Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, surgeon, and/or hospital experience.

MIRA Surgical System Precaution Statement

The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the MIRA Surgical System as a surgical device and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

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