Regulatory Affairs (CMC) Writer – Medical Devices

Job title : Regulatory Affairs (CMC) Writer – Medical Devices

• Location: Hyderabad

About the job

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.  

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health.  

The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams in the area of regulatory compliance, maintenance of product licenses and technical writing of CMC documents. The team members of the global M&S Services Hub will act as partners in carrying out tasks and fulfilling responsibilities to support global quality activities with a focus on technical writing. 

We are seeking a highly skilled and motivated Technical Writer for Medical Devices with a strong engineering background. Significant experience in development of medical devices, drug device combination products and/or primary containers, and creation of Design Control documentation will be an advantage. The ideal candidate will have experience in device development or quality engineering and understanding of Design History File compilation, device risk management, change control management, analytical and technical writing skills, and knowledge of relevant quality and regulatory requirements such as 21 CFR 820, ISO 13485 and ISO 14971. 

Main responsibilities:

• Data collection and alignment: Gather inputs ,Read and analyze regulatory standards and guidelines .Review available platform documents/documents from similar programs Align documents with internal requirements and best practices ,Search and analyze scientific/engineering publications and market observations (competitive intelligence)

• Document development coordination/preparation: Planning and timelines for document creation ,Prepare draft outlines.

• Writing of Design Control documents: Support compilation, maintain and remediate Design History File (DHF), Device Master Record (DMR) and Risk Management File (RMF) Conduct risk analysis for potential hazards associated with the device

• Writing of Healthcare Authority documents: Create summaries/documents for technical file preparation/Notified Body technical package.

• Writing of technical documents, protocols and procedures: Create plans, protocols and reports for device / packaging testing and method validation ,Create traceability matrices,Create technical documents for manufacturing & testing equipment ,Adapt procedures to new regulations, best practices, harmonization and simplification

• Writing of periodic reports and assessments: Create risk assessment reports, periodic safety update reports, complaint investigation reports and trending reports .Perform post market clinical follow up

• Writing of training materials: Develop training materials and sessions

• Review and Approval Management: Administrate the review process ,collect feedback from Global Device & Packaging Unit (GDPU) and revise drafts art approval workflow in electronic document management system (Qualipso) Documentation and knowledge management Retrieve documents/templates

About you:

• Experience:  Significant experience in the medical device industry in the area of device/primary container development, device life cycle management/device maintenance, device engineering and/or quality engineering

• Soft skills:  Strong communication skills, effective in a complex, global organization.  Effective interpersonal skills.  Ability to work collaboratively with cross-functional teams.  Strong analytical and problem-solving skills. Agile thinker and learner, adaptable to dynamic environments. 

• Technical skills:  In-depth knowledge of DHF compilation/maintenance/remediation, device risk management, and change control. Familiarity with medical device and drug device combination products regulations and standards (21 CFR 820, ISO 13485 and ISO 14971). Knowledge of medical device technical standards is preferred (ISO 11040, ISO 11608, ISO 10993, ...). Excellent technical/scientific writing skills and knowledge of statistical analytics.

• Education:  Bachelor’s degree in engineering or related field. Advanced degree in engineering or scientific discipline preferred. 

• Languages:  Verbal and written fluency in English​​.

Why Choose us ?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.