Regulatory Documentation Specialist for Medical Devices

2 days ago


Bengaluru, Karnataka, India Celegence Full time

Celegence is seeking a highly skilled Regulatory Documentation Specialist to join our team. This role involves ensuring the timely development and delivery of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4 and MDR for Medical Devices across various therapeutic areas.

Responsibilities:
  • Develop and deliver regulatory documents in accordance with industry standards and client requirements
  • Collaborate with internal stakeholders and cross-functional teams, including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs
  • Create customized solutions per client needs in terms of language, content, format, and presentation
Requirements:
  • Bachelor's Degree/Post Graduation in relevant Life Sciences field; Master's Degree preferred
  • Minimum 3 years of experience in Medical Device Regulatory documentation
  • Publication experience in scientific journals an advantage
Technical Skills:
  • Knowledge of clinical evaluation and related documents and regulatory requirements
  • Proficiency in comprehension of scientific data and medical terminology and summarizing information from source documents and published literature
  • Proficiency with Microsoft Office (Word, Excel, and Outlook)
Salary: $80,000 - $110,000 per year

This salary estimate is based on national averages and may vary depending on location. We offer a competitive compensation package, including benefits and opportunities for growth and development.



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