Wipro Hiring Medical Writer – Medical Devices

Wipro Limited; Pune District; Presencial; INR 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Wipro is seeking an experienced Medical Writer specialized in Medical Devices for Pune, India. The role focuses on developing and maintaining post-market and clinical regulatory documentation with emphasis on CER, PSUR, PSUR PMCF and PMS deliverables.

The position supports audits and regulatory submissions in coordination with regulatory affairs, quality, and clinical teams. Candidates should have 2–15 years of relevant medical writing experience and a Graduate in Pharmacy, Biomedical

Formación

• Experience in clinical regulatory writing for medical devices (CER/PSUR/PMCF)
• Ability to interpret clinical data and literature for regulatory submissions
• Knowledge of EU MDR, ISO 14155, ISO 13485 guidance and global standards

Responsabilidades

• Develop, review and maintain post-market and clinical regulatory documentation for medical devices.
• Prepare CER, PSUR, PMCF plans/reports and PMS documentation.
• Create trend reports and post-market surveillance summaries.
• Collaborate with regulatory affairs, quality and clinical teams for compliant submissions.

Conocimientos

CER

PSUR

PMCF

PMS

trend reporting

Educación

Pharmacy

Biomedical Engineering

Life Sciences

Descripción del empleo

Medical Writer Jobs – Pharmacy/BME – Pune
Medical Writer hiring in Pune for Medical Devices. CER, PSUR, PMCF experience required. 2-15 years experience.

An excellent opportunity is open for experienced Medical Writers specializing in Medical Devices to join a global healthcare services organization in Pune. This role is designed for professionals with strong expertise in Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS), PSUR, PMCF, and trend reporting aligned with international regulatory expectations.

This position is work-from-office (WFO) and offers long-term exposure to global medical device regulatory projects across multiple geographies.

Company Overview

Wipro is a globally recognized organization providing technology-enabled services and regulatory solutions to pharmaceutical, biotechnology, and medical device companies worldwide. With a strong footprint in healthcare and life sciences, Wipro supports global clients across regulatory affairs, medical writing, clinical research, and post-market compliance.

The organization is known for handling complex regulatory documentation for US FDA, EU MDR, UKCA, and other global markets, offering medical writers an opportunity to work on high-impact, compliance-critical projects.

Job Role & Responsibilities

As a Medical Writer - Medical Devices, you will be responsible for developing, reviewing, and maintaining post-market and clinical regulatory documentation.

Key Responsibilities

• Author, review, and update Clinical Evaluation Reports (CER) in compliance with EU MDR requirements.
• Prepare PSUR, PMCF plans and evaluation reports, and PMS documentation.
• Develop trend reports and post-market surveillance summaries.
• Interpret clinical data, scientific literature, and regulatory guidance.
• Ensure alignment with EU MDR, MEDDEV, ISO 14155, ISO 13485, and global regulatory standards.
• Collaborate with cross‑functional teams including regulatory affairs, quality, and clinical teams.
• Support audits and regulatory submissions by providing compliant documentation.

Required Education

Graduate in Pharmacy, Biomedical Engineering, or Post‑Graduate degree in Life Sciences

Relevant Courses (comma-separated):
Pharmacy, Biomedical Engineering, Life Sciences, Clinical Research, Regulatory Affairs

Experience Requirement

• 2 to 15 years of relevant experience in medical device medical writing
• Proven experience in CER, PSUR, PMCF, PMS, and trend report authoring

Location & Salary

Job Location: Pune, Maharashtra
Work Mode: Work From Office (WFO)

Compensation: Competitive and aligned with industry standards, based on experience and expertise.

Why This Role Matters

This role directly supports medical device safety, regulatory compliance, and patient protection across global markets. By contributing to high‑quality clinical and post-market documentation, medical writers play a critical role in ensuring safe and effective medical device performance throughout its lifecycle.

Frequently Asked Questions (FAQs)

Is relocation to Pune mandatory?

Yes. Candidates must be willing to relocate to Pune and work from office.

Is medical device experience mandatory?

Yes. Experience in medical device regulatory writing, particularly CER, PSUR, and PMCF, is required.

Are remote or hybrid options available?

No. This is a work‑from‑office role.

Summary Table

• Company: Wipro
• Vacancies: Medical Writer - Medical Devices
• Required Education: Pharmacy, Biomedical Engineering, Life Sciences
• Experience: 2-15 years