Product Safety Risk Management Specialist

Job Title

Product Safety Risk Management Specialist

Job Description

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.

Your role:

• 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.

You're the right fit if:

• 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.
• Prefer hands-on experience to lead and execute risk management activities throughout the product lifecycle. In-depth knowledge of ISO 14971 and global medical device regulatory requirements (FDA, MDR, etc.).
• 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).
• 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.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in Gainesville FL is $60,750 to $85,000 Annually.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. 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. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Gainesville FL.

#LI-PHI

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.