Spectranetics

Corrections & Removals Business Process Expert

Spectranetics$134K — $186K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's/Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, or equivalent
  • 5+ years of experience in areas such as Pharma, IVD, Medical Device, Quality Assurance, Quality Control, Clinical Research, or equivalent
  • Minimum of 5 years in Correction & Removal, Field Action, Post-Market Surveillance
  • Experience with global medical device regulations and standards, including FDA and EU MDR
  • Ability to perform required office and remote job functions with or without accommodation.

Responsibilities

  • Serve as a subject matter expert for C&R processes and regulatory requirements
  • Design and evaluate C&R processes with a risk-based and compliant approach
  • Collaborate on a C&R process framework including mapping and documentation
  • Identify and lead improvements for gaps and risks in processes
  • Establish a structured approach for C&R process change requests
  • Explore the use of AI and digital tools to enhance C&R efficiency and knowledge management
  • Monitor the effectiveness of implemented changes and improvements.

Benefits

  • Generous PTO
  • 401k with up to 7% match
  • Health Savings Account with company contribution
  • Stock purchase plan
  • Education reimbursement
  • Eligibility for comprehensive Philips Total Rewards benefits program.
Full Job Description
Job Title
Corrections & Removals Business Process Expert

Job Description

In this role you

Are responsible for ensuring that C&R processes are clear, consistent, effective, well-governed, and aligned with applicable regulatory requirements. The role is particularly focused on process ownership, governance, continuous improvement, execution, knowledge sharing, and enabling consistent C&R practices across the organization.

Your role:
  • Serve as a subject matter expert for C&R processes and ways of working, with a strong understanding of the regulatory foundations, requirements, and expectations applicable to corrections and removals.
  • Apply a regulatory mindset when designing and evaluating C&R processes, considering whether processes are appropriately risk-based, controlled, documented, and capable of meeting regulatory expectations.
  • Work with the C&R Capabilities & Strategy Leader on the C&R process framework, including process maps, procedures, decision points, roles and responsibilities, inputs and outputs, tools, templates, and supporting guidance.
  • Identify gaps, inconsistencies, and risks in C&R processes and lead the development and implementation of practical improvements.
  • Establish and manage a structured approach for C&R process change requests, including intake, assessment, prioritization, stakeholder review, approval, implementation, communication, and effectiveness monitoring.
  • Identify opportunities to use AI and digital tools to improve C&R process efficiency, knowledge management, consistency, decision support, and access to regulatory and process information.


You're the right fit if:
  • Bachelor's/Master's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
  • You've acquired 5+ years of experience with Bachelor's in areas such as Pharma, IVD, Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent.
  • We prefer a minimum of 5 years In Correction & Removal, Field Action, Post-Market Surveillance. Experience with global medical device regulations and standards relevant to C&R/field actions, including FDA requirements, EU MDR, Health Canada, and other applicable global requirements.
  • 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.

The pay range for this position in Bothell, WA is $134,000 to $186,000 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.

#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.

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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