Clin Eval Rédacteur médical

Medtronic plc; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Medtronic plc seeks an experienced Clinical Evaluation Medical Writer to join the regulatory writing team in delivering high‑quality CEP/CER, SSCP, and PSUR documents for implantable medical devices. You will gather and analyze data, prepare manuscripts, abstracts, and summaries, and liaise with regulatory bodies as needed.

Responsibilities include critical appraisal of clinical evidence, literature reviews, and cross‑functional collaboration to ensure ongoing compliance with ISO 13485, ISO

Qualifications

• 4-8 years experience as medical/clinical writer in medical device and/or pharmaceutical industry.
• Strong knowledge of US/EU Quality Systems regulations, ISO 13485, ISO 14971, 21 CFR part 820/11, and EU MDR.
• Excellent written and verbal communication in English; ability to manage multiple priorities.

Responsibilities

• Prepare, edit, and review Clinical Evaluation Reports, clinical study reports, SSCPs, PSURs and related regulatory documents.
• Develop clear, timely responses to audit and submission queries.
• Maintain and search databases of peer‑reviewed literature and clinical evidence.
• Critically appraise and summarize clinical evidence from diverse sources; perform literature searches.
• Collaborate with cross‑functional teams to assess safety and performance of medical devices and support regulatory submissions.

Skills

Clinical writing

Regulatory communication

Literature review

Data analysis

Education

B.Pharm / M.Pharm

M.Sc./Masters in Life Sciences

MBBS or Doctorate

Job description

Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.**Journée type**As a Clinical Evaluation Medical Writer you will be a key member of the Medtronic medical writing team responsible for maintaining highest standards of product reliability and patient well-being through gathering and analysis of data, write reports, and communicate with regulatory agencies as needed on ensuring product safety. The primary responsibilities are creating and maintaining Clinical Evaluation Plans & Reports (CEP / CER), and Summary of Safety and Clinical Performance report (SSCP) and may include associate documentations like Periodic Safety Update Reports (PSUR) etc. that support the presentation, publication, regulatory clinical document submission needs of assigned therapeutic areas including class III and implantable medical devices, Class IIb, Class IIa medical devices. **Responsibilities may include the following and other duties may be assigned:*** Prepare, edit, and review clinical and regulatory documents, including Clinical Evaluation Reports, clinical study reports or summaries, Summary of Safety and Clinical Performance reports, Periodic Safety Update Reports, and responses to Notified Body questions. + Develop clear, accurate, and timely responses to audit and submission-related queries. + Maintain databases of relevant peer-reviewed literature and clinical evidence. + Critically appraise, analyze, summarize, and discuss clinical evidence from all available sources. + Conduct comprehensive literature searches and perform critical evaluations of clinical evidence. + Develop state-of-the-art assessments for assigned product families in alignment with their intended purpose.* Prepare and edit manuscripts, abstracts, clinical study documents, scientific reports, special data summaries, monographs, comprehensive reviews, scientific exhibits, and other medical communication materials for regulatory submissions or internal use, as required.* Collaborate regularly with cross-functional teams to gather and analyze data related to the safety and performance of medical devices and provide solution-oriented recommendations.* Monitor evolving safety regulations, guidance documents, and industry expectations to support ongoing compliance.* Apply knowledge of ISO 13485, ISO 14971, EU MDR, and applicable product-specific industry standards.* Independently identify, assess, and analyze relevant clinical data from scientific publications and other credible sources. **Required knowledge and experience:*** B.Pharma + M.Pharma , M.Sc. / Master’s degree in Pure or Applied Sciences, including Biochemistry, Biotechnology, Microbiology, Nursing, and other relevant Life Sciences disciplines, MBBS degree or a Doctorate in Pure or Applied Sciences.* 4-8 years experiences as a medical/clinical writer in medical device and or pharmaceutical industry. A mix is preferred in case of pharma* Knowledge of US / EU Quality Systems regulations, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards* Strong written, organizational, and communication skills, with a flexible and team-oriented approach.* Strong attention to detail, effective planning skills, and the ability to manage multiple priorities under time-sensitive conditions.* Proficiency in English, including reading, writing, and verbal communication.* Demonstrated learning agility and commitment to continuous professional development. Nice to Have:* Experience working effectively with global and cross-functional teams.* Relevant medical writing industry certifications.