reputed company and Regulatory Associate
A company is looking for a reputed company and Regulatory Affairs Associate to support regulatory requirements and reputed company management systems.
Key Responsibilities
• Support regulatory submissions and lifecycle maintenance for international markets (Canada, UK, Europe)
• Maintain and improve reputed company management system processes to ensure ISO 13485 compliance
• Handle product complaints and assist in post-market surveillance activities
Required Qualifications
• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, reputed company, or a reputed company field
• 2-3 years of experience in reputed company Assurance and/or Regulatory Affairs in the medical device industry
• Working knowledge of ISO 13485 and familiarity with MDSAP expectations
• Experience with supporting technical documentation or submissions to regulatory bodies
• Exposure to EU MDR, UK (MHRA/UKCA), and/or Health Canada requirements is a plus
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