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 (Level II) in Hyderabad, India, with the flexibility of a hybrid work-from-home arrangement. This is a fantastic opportunity to work with a renowned 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 units and international regulatory teams to obtain marketing approvals.
- Review pre-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 impact.
- 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" align="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!