Product Safety Risk Management Specialist

Philips • Gainesville, FL

21d • $60,750 - $85,000 • Onsite

About The Position

Product Safety Risk Management Specialist
In this role you You are responsible for assisting in the development and documentation of the Philips central risk management process, assisting in developing the training materials and deployment packages for process updates and improvements and documenting the minutes for the Community of Practice meetings.

Requirements

• Bachelor's Degree/ Vocational Education in Medical Sciences, Engineering, Life or Physical Sciences, Computer Science/Software development or equivalent.
• Bachelor's Degree OR Vocational Education with 4+ years of technical experience in Medical Safety, Product Development, Post Market Surveillance, Quality Engineering or equivalent.
• In-depth knowledge of ISO 14971 and global medical device regulatory requirements (FDA, MDR, etc.).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.

Nice To Haves

• Prefer hands-on experience to lead and execute risk management activities throughout the product lifecycle.
• Prefer a strong understanding of medical device products with hands-on experience in software development and the lifecycle management of Software as a Medical Device (SaMD).

Responsibilities

• Provides support to the Central Risk Management Team by actively participating in the updates and ongoing maintenance of the Central Philips Risk Management process, ensuring that all risk management procedures are current, effective, and aligned with organizational standards.
• Prepares and compiles reports and presentations regarding product risk management activities and documents clear communication of findings and recommendations.
• Performs routine evaluations to identify and assess potential risks associated with products at every stage of their lifecycle, ensuring that all possible risk factors are thoroughly examined and addressed.
• Utilizes tools and software to track, analyze, and evaluate product risks, ensuring effective monitoring and assessment of potential issues to enhance product safety and compliance.
• Maintains comprehensive and meticulously organized documentation and records related to product risk management compliance, ensuring that all relevant data, procedures, and standards are accurately captured and readily accessible.
• Compiles post-market data for senior risk manager for the rapid identification of emerging risks and trends, providing invaluable insights and a comprehensive understanding of the evolving landscape to healthcare professionals, regulatory agencies, and stakeholders.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level