Risk Management Specialist
hace 1 semana
At Ambit, we are seeking a highly skilled Risk Management Specialist to join our team. In this role, you will be responsible for ensuring the safety and reliability of our products throughout their entire lifecycle.
Key Responsibilities:
- Develop and implement product safety risk management strategies to mitigate potential risks and failures.
- Collaborate with cross-functional teams to execute product safety risk management activities.
- Assess quality information and customer feedback to inform product safety risk management decisions.
- Develop and maintain product-specific safety risk files and policies.
- Collect, analyze, and report data to inform product safety risk management activities.
Requirements:
- Bachelor's degree in a relevant field, such as physical science or engineering.
- 2+ years of experience in a highly regulated industry, preferably in the Medical Device or pharmaceutical industry.
- Thorough knowledge of relevant international ISO/IEC standards, including 13485, 14971, and 62304.
- Experience with regulations and associated guidances, such as MDSAP, MDD/IVDD, and MDR/IVDR.
- Direct risk management experience, such as PRA or FMEA.
What We Offer:
- A competitive salary package based on your profile.
- A permanent contract with opportunities for growth and development.
- A dynamic and supportive work environment.
We are committed to providing a safe and healthy work environment for all our employees. If you are passionate about product safety risk management and have the skills and experience to succeed in this role, we encourage you to apply.
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