Senior Regulatory Affairs Specialist
We are seeking a Senior Regulatory Specialist to join our Medical Device team. The successful candidate will develop strategies and submissions for complex projects related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interaction.
Key Responsibilities:
* Technical Documentation Management
* Global Regulatory Impact Assessments
* Global Regulatory Procedure Updates
* Regulatory Support for R&D Projects
* Technical Solutions for Problem Solving and Quality Improvement
* Clear Communication of Technical Information
* Change Control Activity Review
* Maintenance of Regulatory Procedures
* Quality System Compliance
* RA Team Member for Promotional Materials Review
* Investigation and Solution Recommendation
* Support for Regulatory Inspections
* Liaison with Internal Groups
* Compliance with License Details
* Negotiation with Regulatory Authorities
Requirements:
* Engineering/Science Qualification
* 5 Years of Experience in R&D/QA/RA in Medical Devices
* 3 Years of Experience in R&D, QA/RA, Validations
* 3-4 Years of Experience in Risk, Clinical, and Biocompatibility
* Excellent Technical Writing Skills
* Attention to Detail and Accuracy
* Fluent English Communication
* Problem-Solving Skills
* Data Coordination and Analysis
* Prioritization and Project Management