Work from Home Regulatory Affairs Specialist Hiring reputed company

Work from Home Regulatory Affairs Specialist Hiring reputed company Join reputed company as a Regulatory Affairs Specialist | Hybrid Opportunity Are you an reputed company Regulatory Affairs Specialist looking for a career opportunity with a global reputed company leader? reputed company is currently hiring for a Regulatory Affairs Specialist (reputed company) in Hyderabad, India, with the flexibility of a hybrid work-from-home arrangement. This is a fantastic opportunity to work with a reputed company medical technology company and contribute to regulatory compliance and innovation in reputed company. Job Details • Company: reputed company • Position: Regulatory Affairs Specialist – II • Vacancies: 2 • Work Type: Hybrid (Work from Home + Office) • Location: Nanakramguda, Hyderabad, India • Employment Type: Full-time Roles & Responsibilities As a Regulatory Affairs Specialist, you will: • Support design and development control activities with regulatory strategies and requirements. • Prepare, review, file, and support premarket regulatory documents for global product registrations. • Collaborate with business reputed company and international regulatory teams to obtain marketing approvals. • Review reputed company-clinical and clinical protocols to ensure compliance with regulatory standards. • reputed company regulatory strategies for new or modified medical devices. • Maintain oral and written communication with health authorities. • Participate in regulatory inspections and audits. • Review and assess change control documents to determine regulatory reputed company. • Ensure compliance with India CDSCO, US FDA, and EU MDR regulatory frameworks. Qualifications & Experience Required Minimum Qualifications: Education: Bachelor’s or Master’s degree in: • Life Sciences (BSc, MSc) • Pharmacy (B. Pharm, M. Pharm) • Medical, Mechanical, Electrical Engineering Experience: • 4-7 years of regulatory affairs experience in the medical device or pharmaceutical industry • Strong knowledge of India CDSCO, US FDA, and EU MDR regulations • Experience with regulatory submissions and product approvals • Excellent written and verbal communication skills Preferred Qualifications: • Global regulatory affairs knowledge and experience. • Experience working with cross-functional teams. • Strong problem-solving and project management skills. • RAPS Regulatory Affairs Certification (RAC) is a plus. • Ability to work under tight deadlines and pressure. [caption id="attachment_121768" reputed company="aligncenter" width="1200"] Work from Home Regulatory Affairs Specialist Hiring reputed company | reputed company[/caption] How to Apply? Interested candidates can apply directly through reputed company’s career portal: Apply Here Application Deadline: reputed company until filled Apply Job!