QA/RA specialist

Rapigen America, Inc. is currently seeking an experienced and results-driven Quality Assurance and Regulatory Affairs Specialist. As a Quality Assurance and Regulatory Affairs (QA/RA) Specialist, you will play a crucial role in ensuring compliance with medical device regulations and maintaining high-quality standards. Your responsibilities will span across regulatory submissions, registrations, and listings globally.

Key Duties and Responsibilities; Regulatory Affairs:

• Experts in medical device products’ regulations and guidelines.

• Stay informed about both domestic and international regulatory requirements.

• Closely collaborate with regulatory authorities to ensure compliance during product development, approval, and post-marketing phases.

• Handle the regulatory submissions required for product approval and manage post-marketing activities.

• Play a crucial role in ensuring the safety and efficacy of medical device products.

• Support external regulatory agency audits, providing regulatory input to minimize potential findings of non-compliance.

• Assess and document the regulatory impact of product design changes.

• Participate as an independent reviewer in design projects and Review and approve product change orders and deviations.

Key Duties and Responsibilities; Quality Assurance:

• Adhere to Good Manufacturing Practices (cGMP) to maintain product quality and Create and maintain quality-related documents, including Standard Operating Procedures (SOPs) etc.

• Employee Training and Coaching-Train, motivate, coach, and correct employees to meet quality standards.

• Quality Standards-Set quality standards and communicate them effectively to team members.

• Workflow Coordination-Establish and coordinate quality assurance workflows within the organization.

• Reporting nonconformance-Any malfunctions are promptly reported to production executives for immediate action.

• Collecting Quality Data-Facilitate proactive solutions by collecting and analyzing quality data. Perform inspections, tests, and audits.

• Reviewing Standards-Review current quality standards and policies.

• Documenting Quality Reports-Keeping records of quality reports and relevant documentation.

• Legal Compliance-Ensure compliance with legal standards.

• External Communication-Communicate with external quality assurance officers during on-site inspections.

Qualifications:

• A bachelor’s degree in Natural Science (Biology, Chemistry) or a closely related field is required.

• At least 2-3 years of experience in Quality Assurance/Regulatory Affairs roles, preferably in the bio-industry such as in-vitro diagnostics or medical device companies.

• A proactive and action-oriented professional with an optimistic outlook and the ability to adapt to dynamic business environments.

• Exceptional analytical and critical thinking abilities to understand dynamics and respond effectively.

• Outstanding interpersonal skills and the ability to communicate effectively across various levels to foster strong business relationships.