Regulatory Affairs Specialist

Davita Inc.; Issaquah (WA); Remote; USD 48,000 - 72,000; Full time

Job summary

A leading company in the manufacturing industry is seeking a Regulatory Affairs Specialist to support regulatory submissions for ultrasound devices. Candidates should possess a Bachelor's degree and a minimum of 3 years' experience in China NMPA registration. This remote position offers $60 per hour for a temp role lasting 6 months, requiring a meticulous, self-starting candidate who can navigate detailed regulations and deadlines efficiently.

Qualifications

• Minimum 3 years of experience in China NMPA registration for medical devices.
• Minimum 3 years of experience in preparing and managing regulatory documents.
• Detail-oriented and capable of working independently.

Responsibilities

• Support preparation of regulatory submissions for product approvals.
• Compile regulatory submission documents according to NMPA requirements.
• Coordinate with internal teams to gather necessary documentation.

Skills

Attention to detail

Regulatory compliance documentation

Organizational skills

Mandarin Chinese language proficiency

Education

Bachelor's Degree in Science or Engineering or Medical

Job description

Description

Are you an Regulatory Affairs Specialist looking to join one of the top companies in the Manufacturing Industry?

Are you looking to further your career and grow?

Do you have experience in China NMPA registration for medical devices, preferably ultrasound imaging devices?

If you answered yes to those three questions, then apply today!

Acara Solutions seeks highly qualified candidates to work remotely with our client based in Issaquah, WA. Interested?

Here's what you'd do:

• This role will support the preparation and compilation of regulatory submissions to ensure timely product approvals.
• Prepare and compile regulatory submission documents for ultrasound imaging devices in accordance with 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 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.

Here's what you'll get:

Pay: $60.00 / hr.

Hours: 40 hrs/Week.

Length: Temp (6 months).

Sound like a good fit?

APPLY TODAY

About Acara Solutions

Acara is a premier recruiting and workforce solutions provider-we help companies compete for talent. With a legacy of experience in various industries worldwide, we partner with clients, listen to their needs, and customize visionary talent solutions that drive desired business outcomes. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide.

Job Requirements

Required Skills / Qualifications:

• Bachelor's Degree in Science or Engineering or Medical.
• Minimum 3 years of experience in China NMPA registration for medical devices, preferably ultrasound imaging devices.
• Minimum 3 years of experience in preparing and managing regulatory documents (technical files, CERs, product dossiers).
• Minimum 3 years of regulatory compliance documentation experience.
• Minimum 3 years of experience in China NMPA regulations and standards.

Preferred Skills / Qualifications:

• The ideal candidate will be detail-oriented, well-versed in NMPA regulations, and capable of working independently in a fast-paced, cross-functional environment.
• Solid understanding of NMPA regulations, clinical evaluation requirements, and applicable standards.
• Good organizational and documentation skills with attention to detail.
• Mandarin Chinese language proficiency for working with documentation and stakeholders.
• A self-starter with proven a collaborative mindset.
• Able to meet deadlines, handle shifting priorities, and communicate clearly across teams.
• Familiar with client systems or global medical device manufacturers.
• Mandarin language skills.

Additional Information:

• Upon offer of employment, the individual will be subject to a background check and a drug screen.
• In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are an Equal Opportunity Employer. Race/Color/Gender/Religion/National Origin/Disability/Veteran.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.

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