Bright Bytes Fintech Pvt Ltd is building a regulatory-writing practice for medical device manufacturers selling into the EU. We are hiring an experienced Clinical Evaluation Report (CER) Writer in India (fully remote). Full-time employment or senior freelance/contract engagement - both considered.

WHAT YOU WILL DO

- Author and review Clinical Evaluation Reports (CERs) and Clinical Evaluation Plans (CEPs) under EU MDR 2017/745, MEDDEV 2.7/1 rev 4 and the relevant MDCG guidance (2020-6, 2020-13 and related).

- Design and run systematic literature search protocols; appraise and weight clinical data; document state of the art, benefit-risk and equivalence.

- Review and quality-check first drafts produced with our internal tooling, correcting clinical and regulatory content to Notified Body standard.

- Prepare PMCF plans/reports and PSUR clinical sections and keep CERs updated post-market.

- Draft responses to Notified Body deficiency letters on clinical evaluation.

- Maintain evaluator qualification records (CV, declaration of interests) for each project.

MUST HAVE

- 3+ years writing CERs that have been accepted by an EU Notified Body under MDR (not only MDD legacy).

- Degree in life sciences, biomedical engineering, pharmacy, medicine or equivalent.

- Working knowledge of MEDDEV 2.7/1 rev 4, MDCG clinical evaluation guidance, ISO 14155 and ISO 14971.

- Fluent written English; able to work independently to deadlines.

NICE TO HAVE





- Experience across more than one device class (IIa / IIb / III) or with IVDR performance evaluation.

- Experience with legacy-device CER remediation and Notified Body audits.

COMPENSATION

Open - please state your expectation in your application.

HOW TO APPLY (mandatory - incomplete applications will not be reviewed)

Along with your CV, include the following as text in your application:

1. Expected annual CTC in INR (for full-time) or expected day rate in INR (for contract).

2. A written profile (about one page) covering: device types and classes you have written CERs for; the number of CERs accepted by a Notified Body; which Notified Bodies; and one example of a deficiency you resolved.

3. Your earliest start date.

Shortlisted candidates will complete a short paid sample literature appraisal before interview.

Location: India only (remote). Applications from outside India will not be considered.

Pay: ₹1,200,000.00 - ₹3,000,000.00 per year

Application Question(s):

- What is your expected compensation? State annual CTC in INR for full time, or day rate in INR for contract.
- Written profile (mandatory): list the device types/classes you have written CERs for, the number of CERs accepted by an EU Notified Body under MDR, which Notified Bodies, one deficiency you resolved, and your earliest start date.

Work Location: Remote

📌 Clinical Evaluation Report (CER) Writer - EU MDR Medical Devices (India)
🏢 Bright Bytes Fintech
📍 India