Sr Regulatory Affairs Specialist

Roles and Responsibilities :

• Develop and implement regulatory strategies for medical devices in compliance with EU MDR, US FDA, and other global regulations.
• Collaborate with cross-functional teams to ensure product development meets regulatory requirements and timelines.
• Conduct risk assessments, prepare technical documentation, and submit applications to regulatory authorities.
• Provide guidance on regulatory affairs best practices to internal stakeholders.

Job Requirements :

• 6-9 years of experience in Regulatory Affairs or a related field within the Medical Devices industry.
• Strong understanding of EU MDR (Medical Device Regulation) and USFDA (US Food & Drug Administration) regulations.
• Proven track record of developing successful regulatory strategies for complex medical devices products.