CorSource ยท 15 hours ago
Regulatory Compliance Engineer
Newberg, OR
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expCorSource Technology Group is a locally owned technical staffing and recruiting firm in Portland, Oregon. They are seeking a Regulatory Compliance Engineer to ensure that product safety, performance, and regulatory requirements are met for global markets, leading regulatory strategy and providing subject matter expertise in medical device regulations and compliance.
Cloud ComputingCyber SecurityData ManagementInformation Services
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
Qualification
Required
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
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
Experience within the medical device industry
Regulatory Affairs Professional Certification (RAC)
Company
CorSource
CorSource provides cloud migration, application modernization, cybersecurity, data management, and analytics services.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase