Vigilance Reporting Specialist

Job Title

Vigilance Reporting Specialist

Job Description

In this role you

You will lead complex post-market complaint and adverse-event investigations from intake through closure, ensuring accurate records, timely resolution, regulatory compliance, and clear customer or internal responses. You will also analyze complaint data for product and safety issues, partner cross-functionally on technical investigations, and support the training of new investigators.

Your role:

• •Lead complex complaint and adverse-event investigations, including good-faith follow-up, product or service analysis review, root cause analysis, and clear documentation of findings, actions, and resolution.
• •Analyze complaint data and supplementary information to identify trends, defects, safety concerns, and potential product improvements; develop investigation plans and partner cross-functionally on technical investigations.
• •Ensure accurate complaint coding and records, coordinate new coding requests, and update complaints as information or codes become available.
• •Prepare and review customer response letters and internal responses, escalating complex matters for resolution or regulatory reporting when appropriate.
• •Support the training and qualification of new investigators on complaint handling processes, regulatory requirements, and best practices.

You're the right fit if:

• •Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or a related field; or vocational education with at least 4 years of relevant experience.
• •Experience in medical devices, quality assurance or control, clinical research, complaint management, or a related area.
• •Knowledge of post-market surveillance, QMS and regulatory requirements, technical documentation, data analysis, root cause analysis, and CAPA methodologies. Medical-device vigilance reporting experience is a plus.

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 Nashville TN is $63,000 to $88,200 Annually.

The pay range for this position in Plymouth MN is $67,000 to $92,600 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 Nashville TN or Plymouth MN.

#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.