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.

Responsibilities:

· 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.

Qualifications:

· 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