Regulatory Affairs Specialist

4 weeks ago

Bengaluru, Karnataka, India ResMed Full time

The Regulatory Affairs function at ResMed plays a crucial role in ensuring compliance with regulatory frameworks and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in execution.

Key Responsibilities:

  • Support and maintain internal and government databases relevant to ResMed's operations.
  • Define and communicate requirements for internal systems to ensure alignment with government database requirements.
  • Conduct regular internal reviews of data to ensure accuracy, completeness, and compliance.
  • Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development and business processes.
  • Stay up-to-date with changes in the regulatory environment and best practices.
  • Build productive internal and external working relationships.
  • Occasionally lead project teams and formally train junior staff.

Qualifications and Experience:

  • Bachelor's degree in a related field such as life sciences, legal studies, or healthcare administration.
  • 5-7 years of experience in regulatory affairs, preferably within the healthcare or medical device industry.
  • Strong understanding of enterprise systems, government databases, and regulatory requirements.
  • Excellent analytical and organizational skills, with the ability to manage multiple projects simultaneously.
  • Proficient in Microsoft Office Suite and database management.
  • Strong communication skills, both written and verbal, with the ability to effectively interact with all levels of management and government agencies.

Technical Skills:

  • Proficiency in Regulatory Information Management Systems (RIMS).
  • Experience with data warehousing platforms such as Snowflake.
  • Familiarity with Oracle database systems.
  • Knowledge of document management systems like Objective.

ResMed is committed to creating a diverse and inclusive culture that encourages individual expression and innovative ideas. If you are a motivated and experienced professional looking for a challenging and supportive work environment, we encourage you to apply.

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