Join Dozee as a Regulatory Affairs Associate

 

Join Dozee as a Regulatory Affairs Associate in Bengaluru, Karnataka

Position Name: Regulatory Affairs Associate

Organization: Dozee

Qualification: Not specified

Experience: 1-2 years of experience in Regulatory Affairs within the medical device industry

Salary: Not disclosed

Location: Bengaluru, Karnataka (On-site, Full-time, Associate)

At Dozee, we are committed to delivering high-quality regulatory affairs services. Our team works closely with clients to ensure compliance and accuracy in all regulatory submissions and approvals. Join us and be a part of a dynamic team that makes a difference in the healthcare industry.

Job Description

THE POSITION:

This position involves various responsibilities in regulatory affairs, including compliance with FDA, ISO 13485, MDR, and other relevant regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Participate in the development of regulatory submission and approval strategy in multiple countries.
• Ensure compliance with FDA, ISO 13485, MDR, and other relevant regulatory requirements.
• Maintain awareness and understanding of new and existing regulatory requirements.
• Support identification of applicable regulatory requirements, their impact and how to interpret them.
• Support on generating the required documentation for various submissions.
• Assemble regulatory submission package and support submission process.
• Support audits and inspections by regulatory authorities or notified bodies.
• Assist in the creation, revision, and maintenance of QMS documentation, including SOPs, work instructions, and forms in accordance with ISO 13485.
• Support the coordination and documentation of employee training related to the QMS and regulatory requirements.
• Assist in the administration and tracking of Corrective and Preventive Actions (CAPA).
• Participate in continuous improvement initiatives to enhance the effectiveness of the QMS.

REQUIREMENTS:

• 1-2 years of experience in working in Regulatory Affairs within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, CDSCO, and EU MDR requirements.
• Detail-oriented with strong analytical and problem-solving abilities.
• Experience with regulatory submissions and interacting with regulatory agencies.
• Knowledge of risk management and clinical evaluation processes.

Dozee is a leading provider of medical devices and healthcare solutions. Learn more at https://dozee.health

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