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QA/RA specialist
Rapigen America Inc Rockville, MD

QA/RA specialist

Rapigen America Inc
Rockville, MD
Expired: over a month ago Applications are no longer accepted.
  • Vision , Medical , Dental , Paid Time Off , Retirement
  • Full-Time
Job Description

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.

Address

Rapigen America Inc

155 Gibbs Street

Rockville, MD
USA

Industry

Technology

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