As a Cybersecurity Regulatory Specialist, you will be working as a member of MedCrypt’s Services team. In your role, you will help medical device manufacturers (MDMs) understand how to meet cybersecurity regulatory requirements. You will evaluate medical device manufacturers’ cybersecurity designs and regulatory documentation to demonstrate secure, safe and effective devices. The Cybersecurity Regulatory Specialist will work closely with the Senior Director of Cybersecurity Quality and Safety to perform gap analyses, documentation review, architecture analyses and cybersecurity design assessments.
Duties & responsibilities
- Earn trust with clients, get to the true objectives, and deliver creative or innovative solutions to achieve the clients’ objectives
- Review FDA submission documents related to device indications for use (IFU), device architecture, and cybersecurity
- Engage in tabletop exercises and workshops to resolve documentation and/or design gaps, working collaboratively with the client
- Identify and troubleshoot design gaps in cybersecurity architecture for medical devices when evaluated against best practices/FDA guidance/FDA requirements (per Appropriations Bill)/international standards
Qualifications
- Strong experience working in regulatory affairs or cybersecurity at an MDM, or similar
- Excellent written communication skills, critical thinking, and ability to craft documents that clearly communicate to regulatory authorities
- Familiarity with FDA guidance documents and/or international cybersecurity standards
- Ability to learn/use a wide variety of tools for project management, data capture and analysis
- Strong bias for action and ownership
Bonus
- Previous exposure to FDA (either at FDA, or engaging with FDA through pre-submissions or premarket filings)
- Certifications in cybersecurity domains (CISSP or similar) or background in data privacy in healthcare (HIPAA)
How to Apply
Please submit your resume to talent@medcrypt.co, be sure to include the title of the role in the subject line.
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