We're obsessed with medical device cybersecurity. MedCrypt was started in 2016 to ensure that the medical devices we and our loved ones rely on were as safe and secure as technologically possible. We’re not another cybersecurity company looking to capitalize on the healthcare industry. We are a team of medical device experts who are laser focused on bringing modern cybersecurity features to the next generation of healthcare technology.
The Role
As the Senior Deputy Director, Cybersecurity Quality and Safety, you will be helping the Senior Director to lead MedCrypt’s Regulatory 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 Senior Deputy Director, Cybersecurity Quality and Safety will help lead a team of regulatory specialists and analysts to perform gap analyses, documentation review, architecture analyses and cybersecurity design assessments.
Duties & responsibilities
- Manage projects and staff allocations to ensure success for clients and growth opportunities for team members
- Capture new client opportunities by rapidly converging on the project needs, identifying the true objectives, and determining the appropriate resources to complete successfully
- Aid in marketing our services by Informing potential customers, helping clients develop a sense urgency to act
- Earn trust with clients, 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)
Benefits:
Health insurance
Flexible work schedule
Progressive parental and paid family leave
Unlimited vacation policy
Remote First
Market salaries
401k match
High degree of autonomy
MedCrypt
