Documentation Specialist (QA/Regulatory Affairs)

Company: Morepen Laboratories Limited

Location: Delhi

Position: Documentation Specialist

Experience: 3-5 years

Division: Medipath Research and Development

Job Summary: Morepen Laboratories Limited is seeking a detail-oriented and experienced Documentation Specialist with a strong background in Quality Assurance (QA) and Regulatory Affairs. The ideal candidate will be well-versed in ISO 13485 and ISO 14971 standards and will have experience in managing documentation for medical devices. This position requires a professional with a Masters degree in Life Sciences and 3-5 years of relevant experience.

Key Responsibilities:

• Develop, review, and maintain documentation in compliance with ISO 13485 and ISO 14971 standards.
• Ensure all regulatory and quality assurance documentation is accurate, complete, and up to date.
• Prepare and manage technical files, design dossiers, and other regulatory submissions.
• Coordinate with cross-functional teams to ensure documentation meets regulatory requirements and company standards.
• Conduct internal audits and support external audits to ensure compliance with regulatory standards.
• Implement and maintain document control systems and processes.
• Assist in the preparation of Standard Operating Procedures (SOPs), work instructions, and quality manuals.
• Monitor and update risk management files, ensuring compliance with ISO 14971.
• Support the QA and Regulatory Affairs teams in various compliance activities.
• Stay current with changes in regulatory requirements and industry standards and ensure documentation practices reflect these changes.

Qualifications:

• Masters degree in Life Sciences, Biotechnology, Biochemistry, or a related field.
• 3-5 years of experience in documentation management within the medical device or pharmaceutical industry.
• Strong knowledge of ISO 13485 and ISO 14971 standards.
• Experience with regulatory submissions and quality management systems (QMS).
• Excellent organizational and time management skills.
• Strong attention to detail and accuracy.
• Proficient in using document management systems and software.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.

Preferred Skills:

• Experience in conducting internal and external audits.
• Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Familiarity with other regulatory standards such as FDA 21 CFR Part 820, MDR 2017.