Regulatory Affairs

12 hours ago

Konkan Division, India J D HEALTHCARE LIMITED Full time

Company Overview JD Lifesciences, operating under J D HEALTHCARE LIMITED, i s a fast-growing healthcare company specializing in biomedical equipment and life-saving medical solutions. We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the country. Job Overview We are seeking a detail-oriented and experienced professional to join our team as a Regulatory Affairs Specialist, located in Mumbai Suburban. This is a mid-level, full-time position requiring 4 to 6 years of experience. The selected candidate will play a crucial role in managing regulatory compliance and submissions in accordance with international standards and guidelines. Qualifications and Skills Proven experience with regulatory submissions and a deep understanding of regulatory processes in the medical device industry. In-depth knowledge of FDA regulations and how they apply to product development and compliance in the healthcare sector. Experience with Quality Management Systems, ensuring that company processes align with regulatory and quality standards. Familiarity with ICH guidelines, which guide pharmaceutical product dossier creation and submission. Proficiency in CTD/eCTD compilation for documentation and electronic submissions of regulatory filings. Ability to develop comprehensive regulatory strategies that align with business goals and compliance requirements. Understanding of EU Medical Device Regulations (MDR) and their implications for international product submissions. Skilled in ensuring labeling compliance, making sure product labels meet all necessary regulatory standards. Roles and Responsibilities Prepare, review and submit regulatory documents to ensure timely and efficient product approvals. Conduct regulatory assessments to determine applicable regulatory requirements for new products. Develop and implement regulatory strategies to support product development and compliance initiatives. Ensure product labeling meets regulatory requirements and guidelines in all relevant markets. Monitor changes in regulations and guidelines and communicate impacts to internal stakeholders. Collaborate with cross-functional teams, providing regulatory guidance and support as needed. Maintain regulatory files and databases to ensure all documentation is up-to-date and compliant. Liaise with regulatory authorities as needed to facilitate product approvals and resolve compliance issues.

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