Work Flexibility: Hybrid
What you will do:
Primary Responsibilities
Assist in the facilitation of internal and third-party audits as needed.
Should be capable of interpreting industry standards and government regulations to drive the implementation of world-class processes that may provide resources and/or help to remove obstacles to team accomplishments.
Should have Design Controls expertise for product development projects from inception through successful Design
Should have a basic understanding of product security & Risk Management strategies.
Recommend efficiency and process improvements to product security capabilities and functions.
Collaborate with product teams to assess security risks
Able to clearly convey design control and Product Security-related issues to stakeholders.
Creating Gap assessment between different processes and fulfilling the Gaps. Communicate the security gaps to leadership and propose mitigation solutions.
What You Need:
Knowledge/competence
3-7 years of experience. Basic level Expertise in applying security control frameworks, security risk assessments, and scoring the severity of security threats and vulnerabilities.
Effective verbal and written communicator and consensus-builder
Demonstrated technical problem-solving skills. Strong QMS and SDLC (software development life cycle) understanding.
Basic Understanding of the vulnerability management life cycle.. Experience of working in a regulated medical organization.
Good to have
ISO 13485 standard. Experience in New Product Development for Software and/or Systems preferred
FDA Cybersecurity guidance (including FD&C 524B and eSTAR updates). Hands on experience in using Agile methodology.
Understands security risk management processes preferably in the healthcare or medical device industry
Travel Percentage: None
