Regulatory Compliance Engineer

Regulatory Compliance Engineer

Full-time, Direct Hire –

Start Date:

ASAP

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.

The Regulatory Compliance Engineer will ensure that product safety, performance, and regulatory requirements are met for global markets. This senior‑level, high‑impact 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.

• 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

• 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 work streams
• Ability to work independently and collaboratively in a hybrid team environment
• Proficiency in Microsoft Office; familiarity with relational database systems

• 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)

• Experience with in the medical device industry
• Regulatory Affairs Professional Certification (RAC)

All qualified applicants at Cor Source 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.

Location:

Portland, Oregon

Contact: