Quality Sys Spec I

The successful incumbent will :

·       Manage application, renewal and oversight of import/export permits for explosive precursors and animal source materials supporting both CDG and LSG products.

·       Ensure compliance with relevant Singapore regulations related to regulated materials.

·       Support quality standards and quality management systems at the Singapore Distribution Center.

·       Assist with audits and regulatory surveillance activities.

·       Utilize critical thinking and problem-solving skills to identify root causes and implement corrective actions.

·       Contribute to maintaining regulatory and quality standards within the organization.

How You’ll Make an Impact:

This role involves executing daily tasks related to regulatory compliance, quality assurance and surveillance activities including:

• Manage application, renewal and oversight of import/export license processes for explosive precursors and animal-derived materials for the CDG and LSG products ensuring adherence to local and international regulations.
• Maintaining an up-to-date library of relevant standards, regulations and guidance documents, and monitoring changes to ensure ongoing compliance.
• Participating in the ISO 13485:2016, ISO 9001:2015, SS620:2016 Quality Management System (QMS) to maintain regulatory compliance and supporting internal and external audits.

 What You Bring:

• Diploma or Bachelor’s degree preferably in biology or chemistry or medical technology with 1-2 years of related work experience in a similar role .
• Knowledge of local regulations including those set by the Agri-Food and Veterinary Authority (AVA),  Singapore Police Force (SPF), Health Sciences Authority (H S A) and other Singapore authorities, as applicable.
• Preferably with experience in interacting with the above authorities.  
• Fundamental analytical, communication, problem solving, critical thinking and computer literacy skills.
• Familiarity with policies, practices and procedures relating to Regulatory Affairs and Quality Assurance.
• Good tact, interpersonal skills and the ability to build and maintain cooperative relationships.
• Knowledgeable in SAP.
• Understanding of medical device or reagents related regulation and QMS.
• Ability to work in a regulated environment with specific equipment, tools and physical demands as required.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

 Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and well-being of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.

 EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

  #LI-PL1