Regulatory Documentation Specialist
7 days ago
As a Regulatory Documentation Specialist at Celegence, you will play a crucial role in 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.
The ideal candidate will have a strong background in publication experience, preferably in scientific journals, and a minimum of 3 years of experience in Medical Device Regulatory documentation. A Bachelor's Degree or Post Graduation in any relevant Life Sciences field is required, with a Master's Degree being preferred.
In this role, you will actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs to deliver customized solutions that meet client requirements in terms of language, content, format, and presentation.
You will also be responsible for managing timelines, communicating with team members to maintain awareness of expectations, milestones, and deliverables, and training junior members of the team on technical/process related aspects. Additionally, you will conduct literature searches, screen, appraise, and summarize articles, interpret and present data from device-specific technical documents, and perform editing, proofreading, document formatting, and other document completion/approval activities.
This is an exciting opportunity for a motivated and detail-oriented individual who is passionate about delivering high-quality work and making a meaningful contribution to the company.
Estimated salary: $85,000 - $110,000 per year, depending on location and experience.
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