Regulatory Affairs Executive

**Edusoft Healthcare Pvt. Ltd.** **Company Profile**: Edusoft Healthcare is a leading provider of innovative medical solutions since 2016. We have exclusive partnerships with industry leaders, Carestream Health Inc., USA, LG Electronics, and Genworks Health, India to bring the latest medical technologies to our customers. With a PAN India presence, our team of professionals and channel partners are dedicated to improving patient outcomes through exceptional service and support. We aim to establish ourselves as a leading medical solutions provider and be recognized as a top-tier "bharosemand medical co" in India. **We are hiring for an "Regulatory Executive** **"** **Salary: up to 45k** **Designation : Regulatory Executive** **Walk-In Interview : 13feb - 15feb,2025** **Address**: Edusoft Healthcare Pvt. Ltd. B-83, Mangolpuri Industrial Area, Ph-2 Delhi-110034 **Location: DELHI.** **Gender - Male / Female** **Preffered - Married** **Office Hours : 09:30am to 06:30pm** **Working Days : Second Saturday off and Sundays are fixed off** **Regulatory Executive - Job Description** A **Regulatory Executive** ensures that a company's products comply with all relevant regulations, guidelines, and legal requirements in the industry. They are responsible for obtaining and maintaining approvals, licenses, and certifications for products and services while staying updated with changes in regulatory frameworks. **Key Responsibilities** - **Regulatory Compliance & Documentation**: - Ensure compliance with local, national, and international regulations. - Prepare, submit, and maintain regulatory documents, approvals, and licenses. - Maintain records of regulatory submissions, approvals, and correspondence. - Develop and implement compliance policies and procedures. - **Regulatory Submissions & Approvals**: - Liaise with regulatory authorities for approvals, inspections, and audits. - Track regulatory submissions and address queries from authorities. - **Quality Assurance & Risk Management**: - Conduct internal audits to ensure regulatory compliance. - Identify regulatory risks and implement mitigation strategies. - Collaborate with quality assurance teams to maintain product compliance. - **Industry & Regulatory Updates**: - Monitor regulatory changes and update policies accordingly. - Advise management on regulatory developments affecting the company. - Attend regulatory meetings, seminars, and training sessions. - **Cross-Departmental Collaboration**: - Work closely with R&D, quality control, legal, marketing, and sales teams. - Provide regulatory guidance on new product development and modifications. - Support internal teams in understanding and implementing compliance requirements. **Key Requirements** - **Education**: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related field. - **Experience**: 1-5 years of experience in regulatory affairs, preferably in pharmaceuticals, healthcare, medical devices, or related industries. - **Skills**: - Strong knowledge of regulatory guidelines (e.g., FDA, EMA, CDSCO, ISO, GMP). - Excellent documentation and reporting skills. - Ability to analyze regulatory changes and implement necessary actions. - Strong communication and problem-solving abilities. **Preferred Qualifications** - Certification in Regulatory Affairs (e.g., RAPS, RAC). - Experience handling audits and regulatory inspections. - Familiarity with electronic submission platforms. Thanks and Regards, Nisha Talwar - H.R Manager Pay: ₹30,000.00 - ₹45,000.00 per month **Benefits**: - Cell phone reimbursement Schedule: - Day shift **Experience**: - total work: 2 years (preferred) Work Location: In person