Remidio, a leading medical device and clinical research organization, is hiring a Regulatory Writer for its Bengaluru office. This is a full-time, on-site role ideal for professionals with 2-3 years of experience in regulatory medical writing and clinical documentation.
Advertisement
As a Regulatory Writer at Remidio, you will play a crucial role in preparing clinical regulatory documents for CDSCO, EU MDR, and other international regulatory submissions. This role provides an opportunity to work closely with cross-functional teams and gain expertise in clinical evaluations and post-market surveillance.
Key Responsibilities
- Collaborate with cross-functional teams to collect and analyze clinical data for regulatory submissions.
- Draft, review, and edit Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) Reports, and other regulatory documents.
- Ensure accuracy, completeness, and compliance with CDSCO, EU MDR, and other regulatory guidelines.
- Maintain up-to-date knowledge of regulatory requirements and communicate updates to stakeholders.
- Support regulatory inspections and audits as required.
Required Qualifications
- Bachelor’s degree in a relevant scientific or technical discipline; advanced degrees preferred.
- 2-3 years of experience in regulatory medical writing for pharmaceuticals, biotechnology, or medical devices.
- Proficiency in literature search engines (PubMed, Cochrane, etc.) and ability to extract clinical studies for documentation.
- Experience with CDSCO and EU MDR regulatory submissions is highly desirable.
- Strong written and verbal communication skills to convey complex scientific information clearly.
- Detail-oriented, organized, and able to manage deadlines in a fast-paced environment.
Benefits
- Opportunity to work with a dynamic and growing clinical research team.
- Exposure to global regulatory standards and practices.
- Collaborative work culture with mentorship from experienced regulatory professionals.
- Competitive salary and career growth opportunities.
How to Apply
Advertisement
