Regulatory Compliance Officer

hace 4 días


San José, San José, Costa Rica Genpact A tiempo completo

**About Us:**

At Genpact, we're dedicated to helping businesses achieve their goals through our expertise in digital operations, data, technology, and AI.

We're seeking an experienced Medical Device Reporting (MDR) Specialist to join our team. In this role, you'll be responsible for managing and coordinating all aspects of medical device reporting, ensuring compliance with regulatory requirements and facilitating timely and accurate reporting of adverse events and product malfunctions.

**Key Responsibilities:**

  • Stay current with regulatory requirements and industry developments related to medical device reporting.
  • Represent our company in interactions with regulatory authorities, customers, and internal stakeholders.
  • Coordinate the Medical Device Incident reporting handling process.
  • Manage Health Authority Requests.
  • Determine reportability and escalate as necessary.

**What You'll Need:**

  • Proven experience in medical device regulation and compliance.
  • Strong analytical and problem-solving skills.
  • Ability to work effectively in a fast-paced environment.


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