Junior Regulatory Executive

Maven Profcon Services; Ahmedabad District; Sur place; INR 700 000 - 1 200 000; Plein temps

Résumé du poste

Maven Profcon Services in Ahmedabad, Gujarat, India, is seeking an experienced Regulatory Affairs professional to prepare and review regulatory submissions and clinical trial applications, ensuring alignment with local and international requirements.

You will collaborate with cross-functional teams to develop regulatory strategies, build relationships with authorities, stay current with evolving regulations, and mentor junior staff on regulatory matters.

Responsabilités

• Prepare and review regulatory submissions, including technical documentation and clinical trial applications.
• Conduct thorough analysis of regulatory requirements and ensure compliance with EU MDR 2017/745 standards.
• Collaborate with cross-functional teams to develop and implement regulatory strategies.
• Develop and maintain relationships with regulatory authorities and other stakeholders.
• Stay up-to-date with changing regulatory requirements and industry trends.
• Provide training and guidance to junior staff members on regulatory matters.

Description du poste

• Prepare and review regulatory submissions, including technical documentation and clinical trial applications.
• Conduct thorough analysis of regulatory requirements and ensure compliance with EU MDR 2017/745 standards.
• Collaborate with cross-functional teams to develop and implement regulatory strategies.
• Develop and maintain relationships with regulatory authorities and other stakeholders.
• Stay up-to-date with changing regulatory requirements and industry trends.
• Provide training and guidance to junior staff members on regulatory matters.

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