Product Risk Governance Specialist

2 weeks ago


Bengaluru, Karnataka, India beBeeRisk Full time ₹ 15,00,000 - ₹ 28,00,000
Job Overview

Our organization seeks a highly skilled Product Risk Manager to join our team. As a key member of our risk management community, you will be responsible for identifying and mitigating potential risks associated with our medical devices and health software products.

Key Responsibilities
  • Plan and execute product risk management activities in collaboration with project management teams to ensure the successful launch of our products in an agile development environment.
  • Work closely with cross-functional teams to identify, evaluate, and develop risk mitigation measures for hazardous situations that may occur during the use of our medical devices and health software products.
  • Track the implementation of risk control measures and collaborate with product development teams to ensure their effectiveness.
  • Analyze industry and regulatory sources to identify potential safety risks and participate in the review of product design inputs and outputs.
  • Maintain accurate records of product risk management files and participate in internal and external audits or assessments.
Requirements

To be considered for this role, you must possess:

  • A Master's degree in engineering or a Medical-Technical field.
  • At least 15 years of experience in the medical device industry, with a preference for experience in Software as a Medical Device (SaMD).
  • Proven expertise in risk management for medical devices and health software, including knowledge of relevant standards and regulations such as MDR, ISO 14971, IEC 62304, and ISO 13485.
  • Strong communication skills, assertiveness, self-motivation, analytical, and critical thinking skills.
  • Experience working with international teams and proficiency in written and spoken English.
What We Offer

As a Product Risk Manager at our organization, you can expect:

  • A dynamic and collaborative work environment.
  • Opportunities for growth and professional development.
  • A competitive compensation package.


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