Regulatory Medical Writer (Remedio)

Roles and Responsibilities

Responsibilities:

• Collaborate with cross-functional teams to gather and analyze clinical data for inclusion in regulatory submissions.

• Develop and maintain expertise in CDSCO, EU MDR regulations, and other regulatory guidelines, and standards related to clinical evaluations and post-market surveillance.

• Draft, review, and edit Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS) Reports, and other regulatory documents as required.

• Ensure accuracy, completeness, and compliance of regulatory documents with applicable regulations and guidelines.

• Provide support during regulatory inspections and audits, as needed.

• Stay informed about changes in regulatory requirements and guidelines and communicate implications to relevant stakeholders.

Qualifications:

• Bachelor's degree in a relevant scientific or technical discipline. An advanced degree is preferred.

• At least 0-4 years of experience in regulatory medical writing within the pharmaceutical, biotechnology, or medical device industry.

• Should be proficient in literature search engines like PubMed, Cochrane, etc., and capable of extracting relevant clinical studies for documentation.

• Experience with creating clinical regulatory documents for CDSCO and EU MDR is preferred.

• Strong understanding of regulatory requirements and guidelines governing clinical evaluations and post-market surveillance.

• Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and effectively.

• Detail-oriented with strong organizational and time management skills.

• Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.