CER Technical Medical Writer

Job Title: Medical Writer Fixed Term Contract (12 months, Full Time) - Orthopaedic Devices

Locations: India

Department: Scientific Operations

About the Role:

We are seeking a Medical Writer to join a dynamic scientific operations team supporting medical device projects. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension. The Medical Writer will create, update, and manage a range of regulatory and clinical documents including Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) within their assigned therapeutic area.

Key Responsibilities:

Write and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelines (MUST HAVE)

Participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis

Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices

Compare device safety and performance against the state of the art and investigate unexpected outcomes

Utilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools, to create required documents

Follow all company procedures, regulatory guidelines, and health, safety, and environmental practices

Collaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs

Communicate business-related issues or opportunities to management effectively

Education & Experience Requirements:

BA, BS, or BSN required; advanced degree preferred

Minimum of 3 years experience in medical writing or related roles

Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred

Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus

Strong oral communication, presentation, project management, and prioritization skills

Additional Qualifications/Desirable:

Background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) is welcomed

Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantage

Proven ability to perform literature searches, summarize clinical conditions, and assess risks and benefits for medical devices

Experience reviewing supporting device documentation and analyzing device performance data

This is an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative, cross-functional environment.