Information Technology Medical Devices

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Jim Jing Leng *** Scott Street,

Fremont, CA **539

Cell: 408-***-****

Email: *********@*****.***

Sr. Regulatory Engineer

Experienced safety and regulatory engineering professional with a strong track record in identifying and implementing safety and regulatory compliance requirements for medical devices and information technology equipment (ITE). Proficient in various safety standards including EN60601-1, ANSI/AAMI ES60601-1, CAN/CSA 60601-1, EN60905, UL60950, CAN/CSA-22.2 No. 60950, as well as FDA regulations (21CFR820), ISO 13485, and the 510(K) clearance process.

Skilled in managing projects, with excellent communication and interpersonal abilities. Highly self-motivated and dedicated to ensuring the safety and compliance of medical devices. Professional Experience

NDS Surgical Imaging, LLC, Sarasota, FL (Parent company: Novanta) July 2021 to August 2023

Principle Regulatory Affair Specialist

Continuation of responsibilities from the following role. NDS Surgical Imaging, LLC, San Jose, CA (Parent company: Novanta) May 2007 to July 2021.

Senior Regulatory Engineer

Evaluated proposed products for regulatory classification and jurisdiction

Determined requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities

Provided regulatory information and guidance for product development and planning throughout the

product lifecycle to the regulatory groups and others within the organization Acted as a liaison with various regulatory agencies for safety approvals, inspections, and audits, including UL, TUV, CQC, CCC, BIS, Intertek, ISO, MDR, FDA audits, and international agencies.

Generated GTIN numbers through GS1 agency, managed labeling, and updated and submitted data to the FDA's GUDID database.

Conducted initial supplier qualification inspections for new suppliers, including power supplies, PCBs, and other components.

Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.

Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agencies’ personnel.

Inspected domestic and international supplier design centers and factories, collaborating closely with suppliers to address quality issues.

Prepared for compliance agency inspections and effectively resolved issues during audits.

Worked closely with mechanical and electrical design engineers to address safety concerns and facilitate successful safety approvals. Jim Leng

Tel: 1-408-***-**** R.1

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Provided consultation on safety and regulatory matters throughout the design, manufacturing, and inspection processes, ensuring international market approvals.

Implemented changes such as replacing the UL safety agency with TUV to reduce approval lead time and costs.

Transitioned EMC testing to BACL, enhancing testing quality while reducing costs through the use of an indoor 10-meter chamber.

Collaborated with NDS Surgical Imaging designers, QA, component suppliers, customers, and regulatory agencies to ensure products met worldwide regulatory requirements.

Directly engaged with various regulatory agencies to obtain domestic and international safety approvals and regulatory clearances.

Coordinated and provided regulatory testing support to secure required certifications for target markets, including the US, Canada, Europe, China, Japan, India, and Russia.

Demonstrated adaptability in a fast-paced environment, effectively navigating ambiguity while maintaining safety standards and obtaining product certifications for intended markets.

Conducted Risk Analysis and Safety Fault Tree Analysis.

Specified and qualified internal and external power supplies to ensure they met performance and quality standards for displays and informatics products.

Successfully authored, prepared, and submitted 510(K) applications, securing product clearance, Notify Body approvals, and Health Canada approvals.

Performed internal and external supplier audits in compliance with ISO 9001, ISO 13485, and 21 CFR 820 regulations.

Prepared "Letter to File" documentation to support internal filings for product development projects and product changes.

Possessed a fundamental understanding of RoHS, REACH, and Conflict Minerals regulations.

Conducted risk analysis in accordance with ISO 13485.

Reviewed and updated SOPs in response to changes in the business environment. Elliott Laboratories Inc., Sunnyvale, CA January 2004 to May 2007 Senior Product Safety Engineer

Facilitated communication with safety agencies and conducted witness testing, including UL, CSA, TUV, and various testing labs, to secure safety approvals for clients' new products.

Provided technical support and safety-related consultation for a diverse range of products.

Conducted witness testing for safety agencies and authored CE reports.

Evaluated and performed tests according to international safety standards, including Global IEC60950, Europe EN60950 (Low Voltage Directive 73/23/EEC), United States UL60950 or NRTL or cUL, CAN/CSA-22.2 No. 60950 or CUL, EN61010, CAN/CSA No.22.2 61010, EN60601-1, EN60601-1-1, 3

UL60601-1, CAN/CSA Standard C22.2 No. 601.1, EN529, CB scheme, and national deviations.

Conducted evaluation, testing, and documentation for TCG NEBS Compliance reports, specifically addressing GR-1089-CORE clauses 7 and 9.

Streamlined the quotation process, significantly reducing turnaround times. Managed a small safety department, optimized workload distribution among engineers, and fostered collaboration with other departments to increase the visibility and effectiveness of the safety department. Nortel Networks (formerly Bay Networks), Santa Clara, CA Aug. 1996 to Nov. 2003 Senior Safety Engineer

Reduced approval lead times by conducting in-house witness testing for safety agencies.

Enhanced engineering efficiency by simplifying the submittal process and reducing costs through the consolidation of UL, CSA, and TUV testing with a single compliance agency.

Provided consultation and support to the Mechanical and Power Supply design groups, ensuring safety compliance from product concept to final release, aligning products with domestic and international ITE standards.

Participated in design reviews for new chassis and power supply designs to ensure safety compliance, validated designs, recommended modifications/enhancements, and offered technical support to address safety-related issues, facilitating smooth safety approvals.

Eliminated design confusion by creating Corporate Engineering Guidelines on Product Safety for mechanical design, power supply design, and manufacturing engineering.

Supervised safety inspections across all Bay Networks manufacturing locations, offering technical support and promptly resolving deviations identified by safety agencies.

Managed relationships with safety agencies, including UL, CSA, TUV, NOM, and other testing labs, to secure safety approvals for new products. Homologation Engineer

Provided comprehensive support for international compliance requirements, including marking, labeling, and the overall approval process. Created and reviewed warning labels and compliance markings necessary for FCS (Field Communication System).

Facilitated global WLAN (Wireless Local Area Network) certification for 802.11 a/b, ensuring compliance with FCC, CE, SAR (Specific Absorption Rate), and all domestic and international safety certifications.

Offered technical guidance to OEM and ODM suppliers, assisting them in meeting domestic and international approval requirements, and managed suppliers to obtain all necessary approvals.

Outlined domestic and international safety approval requirements for the BayStack product line and ODM suppliers, including compliance with Global IEC60950, Europe EN60950 (Low Voltage Directive 73/23/EEC), United States Jim Leng

Tel: 1-408-***-**** R.1

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UL60950 or NRTL or ULc, Canada CAN/CSA-22.2 No. 60950 or CUL, Mexico NOM-019-SCFI, and the CB scheme, accounting for all national deviations.

Addressed compliance requirements for EMC (Electromagnetic Compatibility), encompassing standards such as United States FCC CFR47 Part 15, Canada ICES-03, Japan VCCI-A, Europe EN55022, EN61000-3-2, -3, EN55024, Global CISPR22, and CISPR 24.

Additional responsibilities

Evaluated and certified power supplies to align with Nortel Networks specifications throughout the ODM product development cycle.

Led efforts to adapt vendor power supplies, ensuring their compliance with Nortel Networks' specifications for both OEM and ODM products.

Collaborated with the technical publication team, conducting reviews of user manuals and installation manuals. Provided support for international warning label creation, translation, and manual requirements. America Skynet Electronics, Milpitas, CA 1992 to Aug. 1996 Safety Engineer:

Collaborated with domestic and international safety agencies, including TUV, UL, and CSA, serving as the point of contact for all safety-related matters. Managed safety tests and addressed safety issues, overseeing the process from design through certification for both domestic and international safety agencies.

Demonstrated expertise in safety standards, including IEC60950, EN60950, EN60601, UL60950, UL544, and CSA C22.2 No.60950. Conducted Safety witness testing for UL, CSA, and TUV.

Modified flyback switching power supplies to meet client specifications, ensuring compliance with their requirements.

Production Engineer:

Oversaw product evaluation and testing before the products were released for production.

Managed component procurement for the production line.

Developed and documented assembly procedures for new products. Bondwell Industrial Co., Ltd., Fremont, CA 1991

Assistant Product/Marketing Manager:

Managed new product collection, evaluation, and testing with a focus on consumer product development.

Prepared documentation and liaised with UL and other testing labs to secure new safety approvals.

Education:

- BSEE – emphasis on power. San Francisco State University, San Francisco, California.

- Certified Regulatory Affair by University of California Santa Cruz 5

- Certified Product Safety Engineer from iNARTE since 2004. Other:

- Fluent in Chinese - Mandarin

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