PHARMAFull-time
Clinical Evaluation Medical Writer
By Admin · Medical & Scientific Writing
HYDERABAD (IN)HYBRIDPOSTED: 10/2/2026
PHARMAFull-time
HIRING ORGANIZATIONMEDTRONICMedical Devices / Healthcare Technology
ROLE OVERVIEW
Clinical Evaluation Medical Writer responsible for developing and maintaining clinical evaluation and regulatory documents that support the safety, performance, reliability, and regulatory compliance of medical devices.
ROLE DEFINITION & RESPONSIBILITIES
- •Prepare, edit, and review Clinical Evaluation Reports, Clinical Evaluation Plans, clinical study reports and summaries, SSCPs, PSURs, and regulatory documents
- •Develop clear and timely responses to audit, submission, and Notified Body queries
- •Maintain databases of relevant peer-reviewed literature and clinical evidence
- •Conduct comprehensive literature searches and critically appraise, analyze, summarize, and discuss clinical evidence
- •Develop state-of-the-art assessments for assigned product families aligned with intended purpose
- •Prepare manuscripts, abstracts, scientific reports, monographs, reviews, exhibits, and other medical communication materials
- •Collaborate with cross-functional teams to analyze safety and performance data and provide solution-oriented recommendations
- •Monitor evolving safety regulations and guidance and apply ISO 13485, ISO 14971, EU MDR, and applicable standards
Reporting Hierarchy: Reports to the Medtronic medical writing organization; Works collaboratively with clinical, regulatory, quality, safety, and other cross-functional stakeholders
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- B.Pharma plus M.Pharma, or M.Sc./Master's degree in relevant pure or applied sciences, including Biochemistry, Biotechnology, Microbiology, Nursing, or related Life Sciences
- MBBS or Doctorate in relevant pure or applied sciences
- 4-8 years of experience as a medical/clinical writer in the medical device and/or pharmaceutical industry
- Knowledge of US/EU quality systems regulations, ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 11, EU MDR, and product-specific industry standards
- Strong written, organizational, communication, planning, and prioritization skills
- Professional proficiency in English
PREFERRED QUALIFICATIONS
- •Experience with global and cross-functional teams
- •Relevant medical writing industry certification
- •Experience supporting regulatory clinical document submissions and medical device clinical evaluation activities
REQUIRED VERIFIED SKILLS
Clinical evaluation
medical writing
Clinical Evaluation Plan
Clinical Evaluation Report
CEP
CER
SSCP
PSUR
clinical evidence assessment
literature search
critical appraisal
medical device safety
medical device performance
EU MDR
ISO 13485
ISO 14971
21 CFR Part 820
21 CFR Part 11
regulatory writing
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Competitive salary and flexible benefits package; employee resources supporting career and life stages; short-term incentive eligibility through the Medtronic Incentive Plan (MIP)
The posting does not disclose a specific salary range. Compensation is described as competitive and includes eligibility for the Medtronic Incentive Plan; exact compensation should be confirmed through the official recruitment process.
ORGANIZATION CONTEXT & CULTURE
Medtronic is a global healthcare technology company focused on developing medical technologies that alleviate pain, restore health, and extend life. Its mission centers on improving patient outcomes through innovative healthcare solutions.
TEAM SIZE: 95,000+ employees
INDUSTRY: Medical Devices / Healthcare Technology
Culture: Mission-driven and patient-focused environment emphasizing innovation, collaboration, learning agility, quality, regulatory compliance, and continuous professional development.
EXPECTED CAREER ROADMAP
The role can provide progression toward senior medical writing, clinical evaluation leadership, regulatory clinical strategy, medical device clinical affairs, or broader clinical and regulatory leadership positions within a global healthcare technology organization.
APPLICATION ADVISORY
Highlight 4-8 years of relevant medical or clinical writing experience; demonstrate hands-on CEP/CER, SSCP, PSUR, clinical evidence appraisal, and literature-review experience; emphasize knowledge of EU MDR, ISO 13485, ISO 14971, and 21 CFR requirements; showcase medical device or pharmaceutical regulatory writing projects; quantify experience with cross-functional and global teams; tailor the resume to clinical evaluation and regulatory documentation responsibilities.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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