MedCrypt
Senior Deputy Director, Cybersecurity Quality & Safety- $200k + equity
MedCrypt, San Diego, California, United States, 92189
Full Time
Senior Deputy Director, Cybersecurity Quality & Safety - $200k + equity at MedCrypt (United States)Senior Deputy Director, Cybersecurity Quality & Safety - $200k + equity
MedCrypt, United StatesDate Posted: 08 Jun, 2023Work Location: San Diego, CA, United StatesSalary Offered: $200000 yearlyJob Type: Full TimeExperience Required: 6+ yearsRemote Work: YesVacancies: 1 availableWe'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 RoleAs 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 membersCapture new client opportunities by rapidly converging on the project needs, identifying the true objectives, and determining the appropriate resources to complete successfullyAid in marketing our services by informing potential customers, helping clients develop a sense of urgency to actEarn trust with clients, and deliver creative or innovative solutions to achieve the clients’ objectivesReview FDA submission documents related to device indications for use (IFU), device architecture, and cybersecurityEngage in tabletop exercises and workshops to resolve documentation and/or design gaps, working collaboratively with the clientIdentify and troubleshoot design gaps in cybersecurity architecture for medical devices when evaluated against best practices/FDA guidance/FDA requirements (per Appropriations Bill)/international standardsQualifications:Strong experience working in regulatory affairs or cybersecurity at an MDM, or similarExcellent written communication skills, critical thinking, and ability to craft documents that clearly communicate to regulatory authoritiesFamiliarity with FDA guidance documents and/or international cybersecurity standardsAbility to learn/use a wide variety of tools for project management, data capture and analysisStrong bias for action and ownershipBonus: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 insuranceFlexible work scheduleProgressive parental and paid family leaveUnlimited vacation policyRemote FirstMarket salaries401k matchHigh degree of autonomyAbout MedCrypt
Company Size:
11 - 50 PeopleYear Founded:
2016Country:
United StatesCompany Status:
Actively Hiring
#J-18808-Ljbffr
Senior Deputy Director, Cybersecurity Quality & Safety - $200k + equity at MedCrypt (United States)Senior Deputy Director, Cybersecurity Quality & Safety - $200k + equity
MedCrypt, United StatesDate Posted: 08 Jun, 2023Work Location: San Diego, CA, United StatesSalary Offered: $200000 yearlyJob Type: Full TimeExperience Required: 6+ yearsRemote Work: YesVacancies: 1 availableWe'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 RoleAs 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 membersCapture new client opportunities by rapidly converging on the project needs, identifying the true objectives, and determining the appropriate resources to complete successfullyAid in marketing our services by informing potential customers, helping clients develop a sense of urgency to actEarn trust with clients, and deliver creative or innovative solutions to achieve the clients’ objectivesReview FDA submission documents related to device indications for use (IFU), device architecture, and cybersecurityEngage in tabletop exercises and workshops to resolve documentation and/or design gaps, working collaboratively with the clientIdentify and troubleshoot design gaps in cybersecurity architecture for medical devices when evaluated against best practices/FDA guidance/FDA requirements (per Appropriations Bill)/international standardsQualifications:Strong experience working in regulatory affairs or cybersecurity at an MDM, or similarExcellent written communication skills, critical thinking, and ability to craft documents that clearly communicate to regulatory authoritiesFamiliarity with FDA guidance documents and/or international cybersecurity standardsAbility to learn/use a wide variety of tools for project management, data capture and analysisStrong bias for action and ownershipBonus: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 insuranceFlexible work scheduleProgressive parental and paid family leaveUnlimited vacation policyRemote FirstMarket salaries401k matchHigh degree of autonomyAbout MedCrypt
Company Size:
11 - 50 PeopleYear Founded:
2016Country:
United StatesCompany Status:
Actively Hiring
#J-18808-Ljbffr