Digital Compliance Analyst

Are you ready to shape the future of healthcare? At Laerdal Labs D.C., we're on a mission to help save lives through innovative software solutions. Our SimCapture Cloud product is used by over 500 top hospitals, medical schools, and nursing programs in more than 35 countries. If you're passionate about making a real difference and thrive in a dynamic, collaborative environment, we want you on our team! Now, we're looking for a passionate and skilled Digital Compliance Analyst to join our dynamic team!

At a Glance:

As a Digital Compliance Analyst at Laerdal, you will ensure compliance with the regulations and approvals for our electronic and digital products. This role provides vital regulatory support to cross-functional teams, including the CTO, LSO, and Laerdal Global Health, for both new and existing products. You'll be responsible for overseeing product listings, ensuring regulatory adherence, and driving market clearance activities to meet Laerdal's high standards.

What You'll Do:

• Oversee and maintain the approvals and market listings for Laerdal's electronic and digital products.
  

• Issue Declarations of Conformity for Laerdal's product portfolio
  

• Ensure that the Management System is up to date with regulatory requirements specific to electronic and digital products.
  

• Develop strategic plans to secure market clearance in various global markets.
  

• Support the CTO, LSO, and Laerdal Global Health teams with regulatory guidance for new and evolving products.
  

• Coordinate approval processes and market clearance for both new and existing products.
  

• Assist Laerdal sales offices by providing necessary documentation for tender submissions.

• Conduct internal audits of Laerdal's Medical Management System to ensure ongoing compliance.

What We're Looking For:

• Bachelor's degree in computer science, MIS, Information Technology, or equivalent experience in Information Security, Information Technology, or a related discipline
• 3-5 years of experience in the development of digital and/or electronic products, with a basic understanding of relevant cybersecurity regulations.
• Understanding of US and International compliance frameworks such as NIST, ISO, and FedRAMP
• Experience in developing, evaluating, and implementing information security architectures, technologies, standards, and practices to secure applications and IT systems is desirable.
• Flexible, self-motivated, and capable of working independently in a fast-paced environment.
• Excellent critical thinking and troubleshooting skills.
• Strong verbal, written, and interpersonal communication abilities.
• Exceptional time-management skills with the capacity to handle multiple tasks and priorities.
• A customer-first approach in all client and assessment communications.
• Demonstrated commitment to continual learning.
• U.S. Citizenship

Bonus Points For:

• Experience with healthcare simulation devices (e.g., manikins).
• Experience with healthcare learning management software.
• Experience working with (or for) a 3PAO, the PMO, and sponsor agency in an authorization process.
• Familiarity with logging and monitoring tools to execute queries, search/review data for impact.
• Advanced certifications like CompTIA Security+, Certified Information Systems Security Professional (CISSP), Certified Ethical Hacker (CEH), Certified Information Systems Auditor (CISA), CompTIA CySA+, GIAC Security Essentials (GSEC), and Systems Security Certified Practitioner (SSCP)

Ready to join a passionate and fun team dedicated to making a real impact? Apply now and be a part of our mission to help save lives!