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A-dec Inc. · 2 days ago

Regulatory Compliance Engineer, Staff

Newberg, OR

Full-time

Onsite

Lead/Staff

8+ years exp

A-dec Inc. is dedicated to creating high-quality products and services for the dental industry while providing a rewarding employment experience. The Regulatory Compliance Engineer, Staff is responsible for ensuring that A-dec products meet safety, performance, and regulatory requirements for global markets, while also providing technical support on software, cybersecurity, and compliance topics.

HardwareHealth CareManufacturing

Growth Opportunities

No H1B

Responsibilities

Provides deep technical interpretation, guidance, and training on regulatory requirements to various areas including executive leadership, management, and cross-functional teams regarding design, development, evaluation, or marketing of products to ensure regulatory requirements are met

Independently identifies regulatory requirements, develops regulatory strategy, and executes regulatory deliverables to meet project objectives and timelines; partners with Engineering for in-house and/or external testing, when necessary; and maintains documentation

Researches and analyzes state of the art regulatory requirements. Integrates learning through strong collaboration into A-dec product technology design and standard processes to ensure ongoing compliance in this dynamic arena

Supports the design engineering teams to ensure robust and consistent application of regulatory requirements in new designs

Creates deep technical regulatory deliverables to demonstrate product meets applicable regulatory requirements throughout the product lifecycle

Leads regulatory & risk management evaluations on new and existing products to identify risks and review product changes for compliance to regulatory requirements

Manages risk analyses for products and documents the results in a risk management file

Prepares regulatory submissions as appropriate for approval of new or modified products. Ensures submissions are prepared and submitted accurately, completely and in a timely manner to meet business objectives, consulting with regulatory agencies as appropriate for clarification

Supports product approvals by providing requested documentation, resolving open issues, and answering questions, in addition to resolving compliance issues with products in the field

Contributes to the accomplishment of the Regulatory team objectives through effective communication and teamwork, and by providing advanced technical assistance as needed

Remains aware and informed on the global regulatory changes and updates via industry affiliations and third-party collaboration as it relates to software and cybersecurity regulatory compliance (FDA, EU, global). Works with respective teams to ensure A-dec remains compliant to upcoming regulations and executes plans/changes towards compliance

Creates, reviews, and/or approves procedures related to regulatory compliance

Mentors and trains junior regulatory professionals and provides work direction on projects of large scale with significant business impact

Performs other duties as required

Qualification

ISO 13485IEC 60601-1ISO 14971Regulatory Affairs CertificationMedical Device ComplianceProject ManagementMicrosoft OfficeInterpersonal SkillsTechnical Writing

Required

In depth knowledge of applicable regulations and requirements (e.g. ISO 13485, global medical device requirements, IEC 60601-1, ISO 14971, ISO 10993, ISO 17664, ISO 62366, and relevant global guidance)

Strong interpersonal skills to build strong rapport with internal and external customers (e.g. A-dec cross-functional project team members and leaders, regulatory agencies)

Deep technical understanding of the purpose, requirements, and trends of regulations for medical device regulatory compliance, with the ability to read, analyze, and interpret common scientific and technical journals and legal documents, and train others regarding regulatory requirements

Demonstrates intermediate project management skills and experience with the ability to manage regulatory projects effectively

Demonstrates the ability to represent the department and to direct the work of engineers and designers and to provide consulting advice to designers and engineers

Demonstrates ability to work independently with minimal supervision and in a team environment

Demonstrates ability to communicate effectively in oral, written, and illustration form

Proficient in Microsoft Office; Outlook, Word & Excel; working knowledge of relational database software

Bachelor's degree in biology, chemistry, engineering, regulatory affairs or related discipline, and 8+ years of relevant professional or technical experience of increasing responsibility and difficulty in assignments, or the equivalent combination of education and experience