Job Details

Please no C2C or Sponsorship

Staff Regulatory Engineer:

The Staff Regulatory Engineer is responsible for ensuring safety, performance, and regulatory requirements applicable to ensure our products are met for global markets. This position plans, schedules, and leads the regulatory aspects of project assignments requiring independent judgement and a deep technical understanding of the applicable regulatory requirements. The incumbent is also responsible for providing deep technical regulatory support and guidance on product software, cybersecurity, and wireless compliance topics throughout the company. We value diversity in the workplace and encourage women, minorities, and veterans to apply. Thank you!

Type: direct hire

Location: Hybrid

Job Duties And 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 our 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 we remain 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.

Qualifications

• 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. 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.

Education and Experience

• 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.

Preferred Qualifications

• Previous experience in the medical device industry.
• Regulatory Affairs Professional Certification (RAC)