Wipro Hiring Medical Writer – Medical Devices

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

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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.

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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.

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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.

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Eligibility / Qualifications

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

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Location & Salary

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

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

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Application Process

Interested candidates who meet the qualification criteria are requested to share their updated resume via email:

• Email: simran.sagar@wipro.com

Please note that only candidates with the specified qualifications and relevant experience will be considered.

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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.

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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.

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Summary Table

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