Clinical QA & RA Specialist

This role involves supporting quality assurance and regulatory affairs activities related to clinical projects, documentation, and supply chain processes. The specialist will assist in maintaining quality systems, reviewing project and regulatory documentation, monitoring applicable requirements, and supporting compliance with relevant clinical, regulatory, and quality standards. The role will also involve supporting audits, risk assessments, CAPA, change control, and communication of regulatory or quality requirements to internal teams.
Qualifications
Knowledge of quality assurance and regulatory affairs activities within clinical research, healthcare, pharmaceutical, biotechnology, or medical device environments.
Experience with QMS, SOPs, CAPA, change control, risk assessment, and quality documentation.
Understanding of relevant GCP, GMP, ISO 9001, ISO 13485, or other applicable quality standards.
Experience reviewing and maintaining clinical and regulatory documentation.
Familiarity with regulatory requirements related to clinical supplies, medical devices, pharmaceutical products, import/export activities, and country-specific requirements is preferred.
Ability to track regulatory changes and communicate applicable requirements to project and internal teams.
Strong documentation, analytical, and attention-to-detail skills.
Good communication and coordination skills for working with cross-functional teams.
Ability to support audits, identify quality or regulatory risks, and follow established processes.
A bachelor’s or master’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related field is preferred.

Work arrangement
Hybrid