Regulatory Compliance Engineer, Staff

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Regulatory Compliance Engineer, Staff

Apply remote type Hybrid locations Oregon - Newberg Campus time type Full time posted on Posted 30+ Days Ago job requisition id JR100857

At A-dec, we do more than create the highest quality products and services for the dental industry; we strive to deliver a superior employment experience for each of our team members. With an environment that encourages and assists each person in developing to their highest potential, a career at A-dec is incredibly rewarding.

Overview

The Regulatory Engineer, Staff is responsible for ensuring safety, performance, and regulatory requirements applicable to A-dec 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

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 executesregulatory 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 ensureongoing compliance in this dynamic arena.
• Supports the design engineering teams to ensure robust and consistent application of regulatoryrequirements in new designs.
• Creates deep technical regulatory deliverables to demonstrate product meets applicable regulatoryrequirements throughout the product lifecycle.
• Leads regulatory & risk management evaluations on new and existing products to identify risks andreview 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. Ensuressubmissions are prepared and submitted accurately, completely and in a timely manner to meetbusiness objectives, consulting with regulatory agencies as appropriate for clarification.
• Supports product approvals by providing requested documentation, resolving open issues, andanswering questions, in addition to resolving compliance issues with products in the field.
• Contributes to the accomplishment of the Regulatory team objectives through effectivecommunication and teamwork, and by providing advanced technical assistance as needed.
• Remains aware and informed on the global regulatory changes and updates via industry affiliationsand 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 upcomingregulations 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 largescale with significant business impact.
• Performs other duties as required.

Qualifications

Education and Experience

Preferred Qualifications

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not to be construed as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. A-dec reserves the right to assign job duties and days and hours of work based on factors such as workload requirements, staffing levels, and customer demands.

At A-dec, we value our people and show it by prioritizing an inclusive culture, total well-being, and opportunities for learning and career advancement.

A background check and screen for the illegal use of drugs is required.

A-dec is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. In addition, A-dec will not discriminate against applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another.

A-dec is interested in qualified candidates authorized to work in the United States for US-based positions. We are unable to sponsor or take over sponsorship of employment visas.

About A-dec

What's your next thing?

You are a dreamer. A doer. The one who never stops seeking a better way. You are the kind of person we are looking for to join our team.

If you know A-dec, you know that we are a global, family-run company with a big name in the dental industry. But we didn't get here by settling for the status quo. We are perpetually pursuing ways to improve our products and consequently, the lives and well-being of our doctors and patients. A-dec encourages collaboration, believing that curiosity leads to innovation, and diversity and cross-function create the unexpected. We work hard. We play hard. And we never forget that the time you balance outside of work shapes and defines you as a person.

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