Description
We are seeking a highly motivated and detailed-oriented Hardware Regulatory Specialist who will play a crucial role in ensuring Agilent Hardware products comply with all relevant global regulations and standards. She/he will be responsible for interpreting and assessing hardware related international regulations and standards, developing product compliance processes, overseeing the implementation of regulatory and standard requirements, and providing guidance to business divisions as needed.
Responsibilities:
1. Serve as the subject matter expert for Product Safety, EMC, Product Environmental regulations and standards applicable to analytical instruments and IVD instruments (, IEC 61010 series, IEC 60825-1, IEC 61326 series, CISPR 11/EN 55011, FCC Part 15, ICES-001, KS C 9811, KS C 9610-6-1; EN IEC 63000, etc.).
2. Collaborate with Quality, R&D, and Order Fulfillment to ensure safety and EMC by design principles, including electrical safety, mechanical safety, laser safety, fire safety, chemical safety, biohazard safety, etc.
3. Coordinate and oversee Agilent CSA programs as technical account manager, work closely with safety engineers from Quality to ensure CSA Category Program Certification, Surveillance, Factory Inspection in compliance.
4. Work closely with Hardware Test Center and/or external testing labs to ensure Product Safety and EMC testing are performed based on the standards and the reports meet all applicable internal and external requirements.
5. Represent Agilent in IEC, IEEE, and industrial association, and engage in hardware regulation and standard discussion and development to advocate Agilent’s interests.
6. Expert in product environmental regulatory compliance for articles, work closely with Quality, R&D, and Order Fulfillment to ensure instrument compliance to product environmental regulations (RoHS, PFAS, REACH, TSCA, Battery, WEEE, Packaging, Energy Efficiency, Sustainability, etc.).
7. Monitor, interpret, assess, communicate and monitor the implementation status of the new and evolving technical regulations and standards specific to Product Safety, EMC, and Product Environmental compliance. Develop strategies and guidance for businesses to ensure on time implementation of the new requirements in NPI and in-production products.
8. Develop, release, and maintain regulatory compliance Standard Operation Procedures and curriculum specific to Product Safety, EMC, Product Environmental regulations. Provide training and guidance to internal stakeholders as needed.
Qualifications
9. Bachelor’s or Master’s Degree or equivalent in Electrical Engineering or a closely related field with a strong emphasis on hardware technical regulations and standards. Professional certifications in Product Safety or EMC are a plus.
10. Minimum 8+ years of dedicated experience in regulatory compliance, with a strong emphasis on Product Safety, EMC, and Product Environmental compliance for analytical instruments, IVD, or test and measurement equipment.
11. Demonstrated in-depth knowledge and practical application of global regulation and standard requirements through the product life cycle, specifically including:
Product Safety: IEC 61010 series, IEC 60825-1, IEC 62471, UL/CSA standards, Low Voltage Directive, Machinery Regulation, FDA Laser.
EMC: IEC 61326 series, FCC Part 15, EN 55011/CISPR 11, ICES-001, KS C 9811, KS C 9610-6-1, EMC Directive, Radio Equipment Directive, KC, RCM.
Environmental: EU RoHS Directive, China RoHS, REACH Directive, WEEE, Battery Regulation, Packaging and Packaging Waste Regulation, Ecodesign.
12. Experience of monitoring, interpreting, assessing, and implementing new and evolving regulations and standards is required. Active participation in relevant industry associations or regulatory working groups. Experience in advocating for company positions with industries and/or agencies.
13. Strong analytical, problem-solving, and troubleshooting skills, particularly in identifying and resolving Product Safety, EMC, and RoHS compliance issues. Hands-on experience in Product Safety and EMC testing and certification are strongly preferred. Experience of managing and/or working in hardware testing lab and working knowledge on ISO17025 are preferred.
14. Proven experience in managing Material of Concern compliance data collection through the supply chain is preferred.
15. Excellent technical writing and presentation skills, with the ability to effectively communicate complex technical and regulatory information to a broad audience.
16. Ability to work independently and collaboratively in a fast-paced, dynamic environment.
17. Familiarity with Agilent products and the markets Agilent serves is preferred.
Personal Characteristics:
18. Exceptional analytical, data-driven, risk-based, and problem-solving skills with the ability to navigate complex international regulatory landscapes.
19. Outstanding written and verbal communication, presentation, and negotiation skills, with the ability to influence and engage effectively with senior leadership, regulatory authorities, and diverse global teams.
20. Comfortable working with international teams and navigating the complexities of diverse regulatory environments.
21. Ability to identify, understand, and focus on key business priorities.
22. Adherence to the highest ethical standards and ensure regulatory activities are conducted with transparency and honesty.
23. Effectively working with cross-functional teams to build strong relationships and foster a shared understanding of regulatory requirements and responsibilities.
24. Self-starter, team-player, and continuous-learner.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least August 21, 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $121, - $228, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit
Travel Required:
10% of the Time
Shift:
Day
Duration:
No End Date
Job Function:
Quality/Regulatory