QA/RA Associates
Intrinseque Health
New Delhi, Delhi, India3h agovia LinkedIn
About the Role
The role involves supporting quality assurance and regulatory affairs activities related to clinical supplies, medical devices, and equipment used in global clinical trials.
Key Responsibilities
- Reviewing and maintaining quality documentation.
- Assisting with regulatory submissions and certifications.
- Ensuring compliance with ISO standards and applicable regulations.
- Monitoring and auditing processes.
- Coordinating with internal project teams and external partners.
- Contributing to continuous improvement initiatives in quality systems.
- Tracking regulatory changes.
- Supporting risk assessments.
- Preparing reports and summaries for internal stakeholders and clients.
Requirements & Tech Stack
- Proficiency in using standard office software and document management tools.
- Experience with quality or regulatory systems is a plus.
Qualifications
- Strong understanding of quality management principles.
- Familiarity with ISO standards (e.g., ISO 13485, ISO 9001) and good distribution practices.
- Knowledge of regulatory affairs processes, including documentation, submissions, and compliance for medical devices, equipment, or clinical supplies.
- Experience with clinical development or clinical trial operations, particularly in supply chain coordination or documentation.
- Ability to interpret and apply regulatory and quality requirements to operational procedures and project workflows.
- Excellent written and verbal communication skills for preparing reports, SOPs, and regulatory or quality documentation.
- Strong organizational skills with attention to detail and the ability to manage multiple tasks and timelines.
- Bachelor’s degree in life sciences, pharmacy, engineering, or a related field.
- Advanced qualifications or certifications in QA/RA are an advantage.
- Ability to work collaboratively in cross-functional teams.
- Ability to interact professionally with global stakeholders.
- Prior experience in a clinical research, pharmaceutical, biotechnology, or medical device environment is preferred.
Location Preferred: Delhi NCR Region