Company Overview

JD Lifesciences, operating under J D HEALTHCARE LIMITED, is 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.