Regulatory Affairs

3 weeks ago

Chennai, Tamil Nadu, India Ababil Healthcare Full time

Role - Regulatory Affairs - Medical Devices Experience - 1 to 3 Years Location- Madhavaram Chennai Budget - As per the industry Key Responsibilities 1 Regulatory Submissions Prepare and submit regulatory documents to authorities for approval such as new product applications amendments and supplements 2 Compliance Ensure products meet regulatory requirements including safety efficacy and quality standards 3 Regulatory Intelligence Stay up-to-date with changing regulations guidelines and industry standards 4 Risk Management Identify and mitigate risks associated with products or processes 5 Collaboration Work with cross-functional teams including R D Quality and Manufacturing 6 Documentation Maintain accurate and detailed records of regulatory activities including submissions approvals and compliance Requirements 1 Education Bachelor s degree in a relevant field such as life sciences pharmacy or engineering 2 Experience Prior experience in regulatory affairs quality assurance or a related field 3 Knowledge Strong understanding of regulatory requirements guidelines and industry standards 4 Communication Excellent written and verbal communication skills 5 Analytical Ability to analyze complex regulatory information and identify key issues Skills 1 Regulatory writing Ability to write clear concise and compliant regulatory documents 2 Project management Ability to manage multiple projects and prioritize tasks effectively 3 Attention to detail Strong attention to detail and ability to ensure accuracy and compliance 4 Collaboration Ability to work effectively with cross-functional teams and build strong relationships Certifications 1 RAC Regulatory Affairs Certification A certification offered by the Regulatory Affairs Professionals Society RAPS that demonstrates expertise in regulatory affairs Overall a Regulatory Affairs professional plays a critical role in ensuring compliance with regulatory requirements and facilitating the development and approval of products

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