RA Associate Manager

The Regulatory Affairs (RA) Associate Manager plays a pivotal role in maintaining and enhancing the company’s quality management system (QMS) in compliance with ISO 13485 standards and applicable regulatory requirements. This role is essential for ensuring the quality, safety, and compliance of reagent products across their lifecycle, while supporting global market access and regulatory submissions.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regulatory Compliance: Ensuring compliance with regulatory requirements, industry standards, and best practices related to quality assurance and testing. Maintaining awareness of relevant regulations, standards, and certifications applicable to the products or services being developed.

• Submission Management: Prepare and manage regulatory submissions such as technical files and product registrations for Taiwan local and global markets.

• Post-Market Surveillance: Ensure timely reporting of adverse events, field safety corrective actions, and periodic safety updates to regulatory authorities. • Labeling and Marketing Compliance: Review and approve product labeling, marketing materials, and claims to ensure regulatory compliance.

• Regulatory Intelligence: Monitor changes in regulatory environments and assess their impact on company products and processes.

• Leadership and Management: Providing leadership, guidance, and direction to the QA team. Managing team resources, assigning tasks, setting priorities, and ensuring that team members have the necessary skills and support to perform their roles effectively. Job Description TFORM-00040 Revision 02 Effective Date:2022/07/22 BioLegend Taiwan Controlled Document - For Authorized Use Only Page 2 of 4

• Quality Planning: Developing, implementing, and maintaining quality assurance plans, policies, procedures, and methodologies. Defining quality objectives, standards, and metrics to measure and evaluate product quality throughout the development lifecycle.

• Continuous Improvement: Driving continuous improvement initiatives to enhance quality assurance processes, methodologies, and tools. Analyzing testing metrics, identifying trends, and making recommendations for process improvements to prevent defects and improve overall quality performance.

• Risk Management: Identifying, assessing, and managing risks associated with product quality, testing activities, and project delivery. Developing risk mitigation strategies, contingency plans, and escalation procedures to address potential quality issues or project risks.

• Stakeholder Communication: Communicating effectively with project stakeholders, including development teams, product owners, project managers, and senior leadership. Providing regular updates on quality assurance activities, test progress, and quality metrics to ensure transparency and alignment.

• Training and Mentoring: Providing training, coaching, and mentoring to QA team members on quality assurance principles, practices, and tools. Sharing best practices, lessons learned, and industry trends to enhance the skills and capabilities of the team.

• Vendor and Supplier Management: Collaborating with external vendors, suppliers, or third-party testing partners to ensure the quality of outsourced products or services. Establishing quality expectations, monitoring vendor performance, and conducting audits or assessments as needed.

Minimum Qualifications– Education and Experience

• Bachelor’s or Master’s degree in a life science, biotechnology, or related field.

• 5+ years of experience in QA/RA roles, preferably within an ISO 13485-certified organization.

• Strong understanding of quality and regulatory requirements for reagents or similar biotech products.

• Demonstrated experience with QMS management, regulatory submissions, and audits.

• Familiarity with global regulatory frameworks, including FDA, CE-IVD, and other international standards.

• Strong analytical, organizational, and problem-solving skills.

Preferred Qualifications – Education and Experience • Experience with electronic QMS platforms and document management systems.

• Certification in quality or regulatory domains (e.g., CQE, RAC, or ISO 13485 Lead Auditor).

• Knowledge of risk management principles (ISO 14971).

• Strong communication and leadership skills, with the ability to work cross-functionally.

• High attention to detail and being patient at work

• Ability to execute in a fast paced and dynamic environment

• Team player

Work Environment & Physical Demands Office While performing the duties of this job, the employee regularly works in an office setting.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear