Regulatory Affairs

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