Regulatory Affairs Specialist Job at GForce Life Sciences, Issaquah, WA

MFlzNG5QVE1SWFpoV1hRVmVlREVoUUMwNkE9PQ==
  • GForce Life Sciences
  • Issaquah, WA

Job Description

Contract Position: Regulatory Affairs Specialist – China NMPA (Ultrasound Imaging)

Location: Hybrid/Remote (Issaquah, WA preferred)

Duration: 3-6

Industry: Medical Devices – Ultrasound Imaging

Job Summary:

We are seeking a Regulatory Affairs Specialist (Contractor) with hands-on experience in China NMPA registration for ultrasound imaging devices. This role will support the preparation and compilation of regulatory submissions to ensure timely product approvals in China. The ideal candidate will be detail-oriented, well-versed in NMPA regulations, and capable of working independently in a fast-paced, cross-functional environment.

Key Responsibilities:

• Prepare and compile regulatory submission documents for ultrasound imaging devices in accordance with China NMPA requirements.

• Coordinate with internal teams (RA, R&D, Clinical, and Marketing) to gather technical, clinical, and compliance documentation.

• Ensure accuracy and completeness of technical files and CERs (Clinical Evaluation Reports) per Chinese regulatory standards.

• Track submission timelines and support communication with local agents or legal representatives, if applicable.

• Maintain clear records of documentation and submission status to support regulatory audits or inquiries.

Qualifications:

• Bachelor’s degree or above in a scientific, engineering, or medical discipline.

• Minimum 3 years of direct experience with China NMPA registration for medical devices, preferably ultrasound.

• Solid understanding of NMPA regulations, clinical evaluation requirements, and applicable standards.

• Experience in preparing and managing regulatory documents (e.g., technical files, CERs, product dossiers).

• Strong organizational and documentation skills with attention to detail.

• Mandarin Chinese language proficiency preferred for working with Chinese documentation and stakeholders.

• Ability to work remotely or in a hybrid setup from Issaquah, WA, with some flexibility for time zone coordination.

Job Tags

Contract work, For contractors, Local area, Remote job,

Similar Jobs

Yula Boys High School

Varsity Girls Tennis Coach Job at Yula Boys High School

YULA High School Girls Division is looking for an energetic, passionate and experienced coach to serve as the Women's Varsity Tennis Coach. Our school is seeking an applicant who will teach and mold these young women into student-athletes. You must possess excellent communication...

Everest Consultants, Inc.

Principal Dynamics 365 Sales Mentor & Advisor (Part-Time Contract) Job at Everest Consultants, Inc.

Job Title: Principal Dynamics 365 Sales Mentor & Advisor (Part-Time Contract) Industry: DoD / Aerospace Engagement Type: Part-Time (1015 hours/week) | Approx. 2+ Month Contract w/ option to extend Pay rate: $85/hour - $100/hour, W-2 or 1099 I/C **Must work PST...

Delta Airlines

Digital Production Designer Job at Delta Airlines

 ...the production and execution of digital design initiatives across Delta's digital product ecosystem. We seek an innovative problem...  ...company match Comprehensive health benefits including medical, dental, vision, short/long term disability and life benefits A detailed... 

Kerry

RD&A Senior Scientist Raw Materials Category Manager Job at Kerry

 ...Kerry is the world's leading taste and nutrition company for the food, beverage and pharmaceutical industries. Every day we partner...  ...engineering. 5.- Experience in multiple technologies & end use markets a plus. 6.- Ability to drive continuous improvement and change... 

Segway

Bilingual Chinese Mandarin Senior Financial Analyst Job at Segway

 ...ability to work and excel in a team environment Experience with ERP systems with a preference towards SAP Proficiency in Microsoft Office applications, including Excel, PowerPoint, and Power BI Fluent in speaking Chinese/Mandarin at a professional level preferred...