Regulatory Writer

2 weeks ago

Greater Bengaluru Area, India Celegence Full time
Senior Medical Writer Job Opportunity

We are seeking a skilled and experienced Regulatory Writer to join our team at Celegence. As a Senior Medical Writer, you will be responsible for developing high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4 and MDR for Medical Devices.

The ideal candidate will have a degree in Life Sciences, minimum 3 years of experience in Medical Device Regulatory documentation, and expertise in CEP/CER/PMSR/PSUR process. You should also possess excellent communication and writing skills, as well as the ability to work independently and manage multiple projects simultaneously.

The estimated salary for this position is $85,000 per annum, commensurate with your level of experience and qualifications.

Key Responsibilities:
  • Develop high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4 and MDR for Medical Devices.
  • Actively engage with internal stakeholders and cross-functional client business teams.
  • Deliver solutions customized per client requirements.
  • Assist the Team Lead/Manager in the development of schedules to ensure timely delivery.
  • Manage timelines and communicate with team members.
  • Train and mentor junior members of the team.
  • Perform literature searches and summarization of articles.
  • Conduct editing, proofreading, document formatting, and other document completion/approval activities.
  • Interpret and present data from device-specific technical documents.
  • Summarize quantitative data from post-marketing surveillance.
Requirements:
  • Bachelor's Degree or higher in a relevant Life Sciences field.
  • Minimum 3 years of experience in Medical Device Regulatory documentation.
  • Expertise in CEP/CER/PMSR/PSUR process.
  • Excellent communication and writing skills.
  • Ability to work independently and manage multiple projects simultaneously.

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