Job Description

Direct Hire: Lakewood, Colorado, US

Salary: $140000.00 Per Annum

Job Code: 355424

End Date: 2024-11-29

Days Left: 6 days, 1 hours left

Day to Day:

Interpret complex regulatory requirements, ISO 62304, and translate it into actionable guidelines for software development teams.
Develop and maintain a comprehensive compliance program, including policies, procedures, and templates.
Conduct regular audits and assessments to ensure compliance with regulatory requirements.
Collaborate with software engineering teams to integrate regulatory requirements into the SDLC.
Review design documents, test plans, and other relevant documentation for compliance.
Provide guidance on risk management and quality assurance activities.
Mentor and guide software engineers on regulatory compliance best practices.
Lead and coordinate compliance initiatives within the organization.

Must Haves:

10+ years of design control experience
Experience supporting software development and testing in regard to meeting ISO 62304 regulations
Background in software development and strong understanding of SDLC
Bachelor’s degree in Engineering

Pluses:

Recruiter

Phone

Daniel Chandekar

daniel.chandekar@collabera.com

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