Spectranetics

Vigilance Reporting Specialist

Spectranetics$102K — $143K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's/Master's Degree in related fields (Medical Sciences, Healthcare Management, etc.)
  • 3+ years' experience in Medical Device, Quality Assurance, or Clinical Research
  • 3+ years in Post Market, Vigilance Reporting for medical devices
  • Familiar with Quality System, CAPA, and Root Cause investigation
  • Ability to meet physical, cognitive, and environmental job requirements.

Responsibilities

  • Investigate and resolve complex complaints and product/service issues
  • Enforce and coordinate standards for coding in the complaints process
  • Lead comprehensive investigations, condensing key information and findings
  • Prepare and deliver responses to customers or internally as needed
  • Train and qualify new complaint operations investigators

Benefits

  • Generous PTO policy
  • 401k plan with up to 7% company match
  • Health Savings Account contributions by the company
  • Stock purchase plan available
  • Education reimbursement options
Full Job Description
Job Title
Vigilance Reporting Specialist

Job Description

In this role you

You are responsible for investigating and resolving complex complaints, ensuring accurate documentation and analysis, establishing follow-up measures, enforcing coding standards, leading complaint investigations and responses, collaborating cross-functionally for technical investigations, and training new complaint operations investigators.

Your role:

• Investigates and resolves highly complex complaints by monitoring product analysis findings or service analysis notes, documents underlying issues, and ensures the implementation of solutions to address customer concerns efficiently.
• Enforces standards for appropriate coding to records as input for the complaints process, coordinates requests for new coding, when necessary, ensures all systems and tools are updated, and reviews and updates complaints as new codes become available.
• Heads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented.
• Leads customer response letters (CRL) or internal responses, as appropriate, upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution.
• Performs the training and qualification of new PMS complaint operations investigators, provides guidance, resources, and hands-on instruction to facilitate their understanding of complaint handling processes, regulatory requirements, and best practices.


You're the right fit if:

  • Bachelor's / Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
  • 3+ years of experience with Bachelor's in areas such as Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent
  • 3+ years of experience with Post Market, Vigilance Reporting in medical device. Experience in  Quality System, CAPA, Reliability, Root Cause investigation concepts and tools, etc.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this 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.

Philips Transparency Details

The pay range for this position in Bothell, WA is $102,000 to $143,000 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 . 

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.

#LI-PHI

About Spectranetics

Spectranetics is a medical device company that develops, manufactures, and markets single-use medical devices used in minimally invasive procedures within the cardiovascular system. The company's products include laser atherectomy systems, thrombectomy systems, and lead management accessories. Spectranetics was founded in 1984 and is headquartered in Colorado Springs, Colorado. In 2017, the company was acquired by Royal Philips for $2.2 billion.
Learn more about Spectranetics
Size
900 employees
Industry
Founded
1980

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