Product Security Regulatory & Process Analyst

JOB TITLE:

Product Security Regulatory & Process Analyst

LOCATION:

REMOTE

REMOTE OK: YES

CLIENT

LOCATION:

DENVER, CO HQ AND WORLD

RATE: 60-80/hr

CONTRACT TO HIRE: YES

CONTACT:
Brian Merin; ;

• Client designs, engineers, and builds medical technology that helps save lives. The Product Security Regulatory & Process Analyst plays a key role in strengthening and sustaining product security governance for regulated medical devices. Rather than focusing on hands on security testing or operations, this role concentrates on interpreting regulatory and industry cybersecurity requirements, assessing their applicability, and shaping how those requirements are implemented, documented, and sustained.
• This position partners closely with Product Security Engineers, R&D, Quality, and Regulatory Affairs to translate evolving cybersecurity regulations and standards into clear, auditable, and practical product security processes.

• Medical Device Experience
• Cybersecurity/Security
• experience in a regulated environment such as Quality, Regulatory Affairs, Systems Engineering, Software Development, or Cybersecurity
• Understanding of FDA Regulations related Medical Device Products
• Experience working with regulated products, development processes
• Ability to work collaboratively across engineering, quality, regulatory, and security teams
• Interest in medical device cybersecurity and willingness to grow expertise in this evolving regulatory area
• Comfortable influencing without direct authority and navigating ambiguity

• Serve as a product security regulatory and process subject matter expert, supporting compliance with FDA cybersecurity guidance and global medical device regulations.
• Support the creation, maintenance, and continuous improvement of product security Policy, SOPs, and work instructions.
• Own or support product security quality plans and CAPA activities, including documentation, tracking, and coordination with cross functional stakeholders.
• Translate product security requirements into clear, actionable requirements and ensure traceability within the requirements tool.
• Partner with Product Technical Leads (PTLs), R&D, and Product Security Engineers to ensure product security activities align with quality plans and lifecycle expectations.
• Support internal audits, regulatory inspections, and readiness activities related to product security.
• Monitor adherence to defined product security processes and identify gaps or improvement opportunities.
• Act as a connector between Product Security, Quality, and Regulatory teams to ensure consistent execution and communication.