Regulatory Expert

Carenx Innovations; Navi Mumbai; On-site; INR 800,000 - 1,400,000; Full time

Job summary

Carenx Innovations in Navi Mumbai is seeking a Regulatory Affairs Specialist to develop and implement regulatory strategies for medical devices and to prepare and submit regulatory documents to authorities.

The role requires reviews of submissions for accuracy, collaboration with cross-functional teams, staying updated with regulatory changes, and providing guidance on regulatory matters to internal stakeholders. Experience with CDSCO, CE and ISO 13485 is preferred.

Qualifications

• Strong knowledge of regulatory affairs and compliance.
• Experience with CDSCO, CE, ISO 13485 regulations.
• Excellent communication and project management skills.
• Ability to work independently and as part of a team.
• Strong analytical and problem-solving skills.
• Familiarity with medical device industry regulations and standards.

Responsibilities

• Develop and implement regulatory strategies for medical devices.
• Prepare and submit regulatory documents to relevant authorities.
• Conduct thorough reviews of regulatory submissions to ensure accuracy and completeness.
• Collaborate with cross-functional teams to meet regulatory requirements.
• Stay updated with changing regulatory requirements and guidelines.
• Provide training and guidance on regulatory matters to internal stakeholders.

Skills

Regulatory affairs

Project management

Communication

Team collaboration

Analytical thinking

Job description

• Develop and implement regulatory strategies for medical devices.
• Prepare and submit regulatory documents to relevant authorities.
• Conduct thorough reviews of regulatory submissions to ensure accuracy and completeness.
• Collaborate with cross-functional teams to meet regulatory requirements.
• Stay updated with changing regulatory requirements and guidelines.
• Provide training and guidance on regulatory matters to internal stakeholders.

Job Requirements

• Strong knowledge of regulatory affairs and compliance.
• Experience with CDSCO, CE, ISO 13485 regulations.
• Excellent communication and project management skills.
• Ability to work independently and as part of a team.
• Strong analytical and problem-solving skills.
• Familiarity with medical device industry regulations and standards.