Responsibilities:

• Interface with clients to gather information and review documentation for correctness and compliance with regulatory guidelines in order to develop submission quality documentation for marketing applications.

• Conduct risk management and vulnerability analyses on medical devices and support manufacturer’s cybersecurity strategy development, system testing and evaluation, and verification and validation efforts.

• Review client documentation to identify and inform recommendations for improving policies, processes, and procedures based on new and/or evolving Federal standards, requirements and/or guidelines.

• Research, review, monitor, and report on industry best practices, latest cybersecurity developments and trends, standards, and guidelines, and apply these to services provided.

• Stay current on US medical device regulatory requirements.

Qualifications:

• Bachelor’s degree required; advanced degree preferred.
• 5-10 years working within information/cyber security/FDA cyber Regulatory required. Engineering or science background with at least 3 years of consulting or client facing experience preferred; direct healthcare and/or medical device experience preferred.
• Should understand medical device development concepts and a technical background to assist with software, cybersecurity and clinical strategies and be able to effectively communicate these strategies to internal team members and clients.
• Possesses US regulatory experience/fluency with FDA regulations.
• Experience with FDA pre- and post-market management (emphasis on premarket) of cybersecurity of medical device guidance documents is preferred.
• Familiarity with information threat analysis and risk assessments (e.g., TIR57, ISO 14971) and detection concepts and principles and impact based on industry best practices (e.g., NIST framework, ISO 27001, Center for Internet Security (CIS) controls).
• Demonstrated technical proficiency. Has worked on moderately complex problems where analysis of situations or data requires evaluation.
• Knowledge of threat modeling, penetration testing, cybersecurity research, and knowledge of encryption technologies, ethical hacking, and endpoint security tools is preferred.
• Entrepreneurial and self-motivated, especially in the face of ambiguity and imperfect knowledge/data.
• Strong communication skills (this will be a client facing position).
• Ability to manage tasks independently and take ownership of responsibilities.
• Ability to adapt to a rapidly changing environment and quickly identify new trends and industry changes specific to security and advanced cyber-attacks.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

The potential base pay range for this role, when annualized, is $107,800.00 - $300,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.