What are the responsibilities and job description for the Regulatory Compliance Engineer position at CorSource?
We are CorSource Technology Group, a locally owned technical staffing and recruiting firm in Portland, Oregon.
We encourage you to submit your resume to the job posting link or reach out directly: recruiting@corsource.com
Title: Regulatory Compliance Engineer
Location: Hybrid, 2–3 days per week on-site (Newberg, OR)
Employment Type: Full-time, Direct Hire
Start Date: ASAP
About the Company
Our client is a long-standing, industry-leading manufacturer of complex equipment used in clinical environments. Known for innovation, high-quality engineering, and a strong people-centered culture, the company provides an environment that encourages professional growth, collaboration, and continuous improvement.
They offer a stable, mission-driven workplace where technical teams are empowered to develop high-performing products supported by strong values around quality, integrity, teamwork, and open communication.
Role Overview
The Regulatory Compliance Engineer will ensure that product safety, performance, and regulatory requirements are met for global markets. This role leads regulatory strategy, creates technical documentation, supports product design teams, and provides subject matter expertise in global medical device regulations, software compliance, cybersecurity, and wireless standards.
This is a senior-level, high-impact role that requires deep technical regulatory expertise and the ability to guide cross-functional teams.
Key Responsibilities
• Provide advanced interpretation and guidance on global regulatory requirements to engineering, leadership, and cross-functional teams
• Identify applicable regulations, develop regulatory strategies, and manage regulatory deliverables for product and design initiatives
• Partner with engineering to plan and execute testing (internal or external), ensuring appropriate documentation is completed
• Stay current on evolving regulatory standards, especially related to software, cybersecurity, and wireless compliance
• Support design engineering to ensure regulatory requirements are applied consistently throughout product development
• Create and maintain regulatory documentation throughout the product lifecycle
• Lead regulatory and risk management evaluations for new and existing products
• Manage risk analyses and maintain risk management files
• Prepare regulatory submissions for new or modified products and coordinate with regulatory agencies as needed
• Respond to compliance issues, documentation requests, and post-market questions related to product safety and performance
• Provide mentorship and support to junior regulatory team members
• Contribute to continuous improvement of processes, documentation, and regulatory workflows
• May perform other related duties as assigned
Qualifications
• Deep understanding of global medical device regulations and standards (e.g., ISO 13485, IEC 60601-1, ISO 14971, ISO 10993, ISO 17664, ISO 62366)
• Strong communication and interpersonal skills with the ability to train, influence, and collaborate with cross-functional teams
• Ability to interpret complex regulatory, scientific, and technical information and apply it to product development
• Demonstrated project management capabilities and experience leading regulatory workstreams
• Ability to work independently and collaboratively in a hybrid team environment
• Proficiency in Microsoft Office; familiarity with relational database systems
Education & Experience
• Bachelor’s degree in engineering, biology, chemistry, regulatory affairs, or related field
• 8 years of progressively responsible experience in regulatory engineering or compliance (medical device experience preferred)
Preferred Qualifications
• Experience within the medical device industry
• Regulatory Affairs Professional Certification (RAC)
All qualified applicants at CorSource Technology Group will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Does this position sound interesting, but perhaps not for you? If you know of a friend or colleague that could be a match, your referral could be worth a referral bonus.
recruiting@corsource.com