Complaint Handling Business Expert

Job Description

In this role you

The Complaint Handling Clinical Expert is responsible for conducting clinical reportability assessments, guiding specialists through complex complaint assessments, resolving technical escalations, managing regulatory communications, ensuring compliance with standards, driving continuous improvement, and participating in post-market surveillance activities to uphold regulatory compliance and patient safety.

Your role:

• Conducts moderate clinical reportability assessment, applies clinical subject matter expertise to assess events for reportable death or serious injury, and utilizes clinical experience and judgment to guide other specialists through complex complaint assessments.
• Partners with technical experts, resolves complex escalations such as technical investigations, IIAs, and CAPAs, escalates concerns to leadership to address aging investigations affecting KPIs, including technical investigations, IIAs, CAPAs, and risk reviews.
• Records, investigates, and resolves complex complaints, evaluates initial assessments of reportability, promptly escalates to the manager for further determination and necessary action, and ensures thorough analysis and resolution.
• Applies clinical judgment to lead the team through detailed complaint assessments, ensuring comprehensive analysis and appropriate action.
• Supports liaising with regulatory authorities, manages all communications, addresses inquiries, provides required documentation, and ensures compliance with regulatory standards and adheres to regulatory reporting processes, maintains up-to-date records to facilitate effective interactions and upholds the highest standards of regulatory compliance and patient safety.

You're the right fit if:

• Bachelor's/Master's Degree in Clinical Research, Occupational Health and Safety, Environmental Health, Industrial Hygiene, Engineering or equivalent OR in a licensed/certified capacity in a health care role such as an RN, NP, PA, MD, (Respiratory Therapist, Radiation Technologist, Ultrasound Technologist, CT technologist, EMT, etc.
• 3+ years of experience with Bachelor's in areas such as Clinical Research, Quality Assurance, Market Surveillance, Clinical Operations or equivalent OR no prior experience required with Master's Degree.
• Have understanding and practice with 21 CFR 820.198 Complaint Handling, 21 CFR 803 Medical Device Reporting, and related guidance documents, data analysis, and specifically trending analysis
• Have general understanding of the balance of 21 CFR 820, ISO 13485, and related guidance documents,understanding of Safety Risk Management including 1SO 14971 and its guidance TS 24971.
• 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 Bothell, WA is $97,000 to $135,000 Annually.

The pay range for this position in Cambridge, MA is $97,000 to $135,000 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 Bothell, WA or Cambridge, MA.

#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.