Senior Regulatory Compliance Specialist

5 days ago

Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 18,64,197 - ₹ 25,98,419

**Regulatory Affairs Program Manager Job Summary**

The position of Regulatory Affairs Program Manager requires strategic regulatory recommendations to the business group. This role involves ensuring continued compliance with applicable regulations and developing comprehensive regulatory strategies for new devices and significant post-market changes.

Key Responsibilities:
  • Provide accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
  • Assess product changes for impact on global regulatory registrations.
  • Develop detailed written regulatory plans to support international regulatory submissions and global product sales.
  • Review and approve advertising, promotional items, and labeling for regulatory compliance.
  • Perform regulatory impact and compliance evaluations to support engineering changes and post-market activities.
  • Maintain knowledge of current regulatory standards, procedures, and changes.
Requirements:
  • A bachelor's degree in Regulatory Affairs, Engineering, or a science-related field (a master's or Ph.D. is preferred).
  • At least 8 years of experience in the medical device industry, including EU MDD, Health Canada, China, U.S. FDA Class II, and/or Class III, etc.
  • Knowledge of regulations applicable to software, including Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).
  • A strong background in Design Controls.
  • Proficient knowledge of medical device regulations, FDA law, MDD/MDR, other global laws, regulations, and standards.

We are seeking a highly skilled professional with expertise in regulatory affairs and a passion for delivering exceptional results.

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