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
This position partners with Product Technology and is responsible for ensuring safety, security, performance, risk management, and regulatory requirements applicable to A-dec products are met for global markets with a primary focus on software, cybersecurity, and wireless compliance. This position independently plans, schedules, and leads the regulatory aspects of project assignments, applying extensive and diversified knowledge 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. This includes but is not limited to physical product software, mobile/web product application, and data exchanges such as API’s.
Duties and Responsibilities:
- Represents the department with considerable independent judgement and provides technical interpretation, guidance, and training on software and cybersecurity 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 identify regulatory requirements, develop regulatory strategy, and execute regulatory deliverables to meet project objectives and timelines; partners with Product Technology for in-house and/or external testing, when necessary; and maintain documentation.
- Research and analyze state of the art regulatory requirements related to software, cybersecurity, wireless, and other technology-related topics. Integrate learning through strong collaboration into A-dec product technology design and standard processes to ensure ongoing compliance in this dynamic arena.
- Support the Product Technology Teams to ensure robust and consistent application of software, cybersecurity, and wireless regulatory requirements in new designs.
- Lead software and cybersecurity regulatory & risk management evaluations on new and existing products to identify risks and review product changes for compliance to regulatory requirements.
- Manage software and cybersecurity risk analyses for products and document the results in a risk management file.
- Prepare 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.
- Support product approvals by providing requested documentation, resolving open issues, and answering questions, in addition to resolving compliance issues with products in the field.
- Contribute to the accomplishment of Regulatory team objectives through effective communication and teamwork, and by providing advanced technical assistance as needed.
- Remain aware and informed on the global regulatory changes and updates via industry affiliations and third-party collaboration as it relates to software, cybersecurity, and other regulatory requirements (FDA, EU, global). Works with respective teams to ensure A-dec remains compliant to upcoming regulations and execute plans/changes towards compliance.
- Create, review, and/or approve procedures related to regulatory compliance. POSITION: Regulatory Engineer, Senior Staff –Technology
- Mentor and train junior regulatory professionals and provide work direction on projects of large scale with significant business impact.
- Perform other duties as required.
Minimum Qualifications:
Bachelor’s degree in Engineering, Technology, or Regulatory Affairs or related discipline, and 10+ years of relevant professional or technical experience of increasing responsibility and difficulty in assignments or the equivalent combination of education and experience
In depth knowledge of applicable regulations and requirements (e.g. ISO 13485, global medical device requirements, IEC 60601-1, IEC 60601-4-5, IEC 62304, ISO 62366, ISO 14971, UL 2900 series, IEC TR 80001 / 80002 series, ISO 27000, IEC 62443 series, 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, interpret common scientific and technical journals and legal documents, and train others regarding regulatory requirements.
Demonstrates advanced 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.
Proficiency in Microsoft Office; Outlook, Word & Excel; working knowledge of relational database software.
Preferred Qualifications:
- Previous experience in the medical device industry is preferred.
- Previous experience with embedded and cloud-based software development practices.
- Previous experience with Jira and Jama.
- Regulatory Affairs Professional Certification (RAC) preferred.
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. *VEVRAA Federal Contractor”
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.
