Recruitment: Quality Assurance and Regulatory Affairs Manager (Life Science Products)

Job Description

Job Title: Quality Assurance and Regulatory Affairs Manager (Life Science Products)

Location: Remote


Company Overview:

Sunresin is a leading company manufacturing Ion exchange resins, adsorbents and specialty resins for different industries. Sunresin has its headquarter in Xi’an China and is rapidly expanding globally. For our international Life Science division we looking for a Regulatory and QA manager able to assist the company growing in this field.

The position can be remote, travelling to headquarter is required to connect with Team


Job Description:

As a Quality Assurance and Regulatory Affairs Manager, you will play a critical role in ensuring compliance with regulatory standards and maintaining the highest quality standards throughout our life science product manufacturing processes. You will be responsible for managing quality assurance programs and regulatory affairs activities to ensure our products meet or exceed industry regulations and customer expectations.



· Develop and implement quality management systems, policies, and procedures to ensure compliance with relevant regulatory requirements (e.g., FDA, ResAp, Halal, Kosher, ISO, GMP and all local national compliances when required).

· Establish and maintain effective relationships with regulatory authorities and notified bodies to facilitate product registrations, submissions, and audits.

· Provide guidance and support to cross-functional teams during product development and manufacturing processes to ensure compliance with regulatory and quality requirements.

· Review and approve product labeling, CoA, MSDS, promotional materials, and documentation to ensure compliance with regulatory guidelines.

· Stay up to date with relevant regulatory changes and industry trends, and provide proactive guidance to management on potential impact and necessary actions.

· Coordinate and support regulatory inspections, customer audits, and external assessments.

· Conduct risk assessments and participate in the development of risk management strategies.

· Collaborate with cross-functional teams to investigate and resolve quality issues, non-conformities, and complaints in a timely manner.

· Train and educate employees on quality and regulatory requirements to promote a culture of quality awareness and continuous improvement.



· Bachelor's degree in a relevant scientific or engineering discipline. A master's degree is a plus.

· Proven experience in quality assurance and regulatory affairs within the life science industry.

· Solid knowledge of international regulations and standards, such as FDA, ResAp, Halal, Kosher, ISO, GMP, GB Chinese standards.

· Experience with regulatory submissions, product compliance and audits.

· Excellent analytical, problem-solving, and decision-making skills.

· Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams located worldwide.

· Detail-oriented and organized, with the ability to manage multiple priorities in a fast-paced environment.

· Proficient in English and Chinese.


We appreciate all applications.

Thank you for considering this opportunity with our company.

Send your application to info.lifescience@sunresin.com

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Contact Us

Sunresin Park,No.135, jinye Road, Xi’an Hi-tech Industrial Development Zone, Shaanxi-710076, China
seplite@sunresin.com +86-29-89182091
Our Product List
Bio-Pharmaceutical & Life Science
Modern biopharmaceutical technologies typically use biological microbial fermentation...
Chemical Industry
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Drinking Water Treatment
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Food & Beverage Industries
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Hydrometallurgy & Mining
Hydrometallurgy is a technique for extractive metallugry involving the three general area...
Direct Lithium Extraction (DLE)
Sunresin is the major DLE lithium sorbent producer in China which mainly used for extraction lithium from salar brine and geothermal brine etc with high efficiency.
Industry Water Treatment
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Plant Extraction
Plant Extraction is a process to gather the trace bioactive compounds from the tissue of a plant.
VOCs Treatment
With the widespread use of chemical products in the industry, more and more organic...
Wastewater Treatment
Wastewater treatment is the process of converting wastewater into an effluent that can be discharged
Latest News
2024 01
 Sunresin has been selected for the Hang Seng China A Specialised & Sophisticated 50 Index
On January 22, Hong Kong's Hang Seng Index Company launched the "Hang Seng China A Specialised & Sophisticated 50 Index", and Sunresin (300487.SZ) was successfully selected as a constituent stock. As of January 12, 2024, the proportion was 2.78%.
2023 11
 Sunresin Participates in Morgan Stanley 22nd Annual Asia-Pacific Summit
Sunresin, a leading technology company, was invited to attend Morgan Stanley's 22nd Asia-Pacific Summit in Singapore from November 15th to 16th. This summit is a pivotal conference for institutional investors in the Asia-Pacific region.
2023 11
 Sunresin won the 2023 Forbes Asia Top 200 and was invited to attend the award ceremony
On November 21, the Forbes Asia Best Under A Billion Forum & Awards Dinner was held in Manila, Philippines. We are proud to announce that Dr. Gao Yuejing, chairwoman of Sunresin, has been invited to attend the award ceremony and has received for the second time this honor since 2020.

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