Spectranetics

Corrections & Removals Expert

Spectranetics • $95K — $150K *
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 experience in Pharma, IVD, Medical Device, Quality Assurance, or Clinical Research.
  • Minimum 5 years in Correction & Removal, Field Action, or Post-Market Surveillance.
  • Experience with global medical device regulations including FDA, EU MDR, and Health Canada.
  • Ability to fulfill physical, cognitive, and environmental job requirements.

Responsibilities

  • Serve as a subject matter expert for Corrections & Removals (C&R) processes.
  • Design and evaluate C&R processes with a regulatory mindset.
  • Collaborate with leadership on the C&R process framework and related documentation.
  • Identify gaps in C&R processes and lead improvements.
  • Manage structured approach for C&R process change requests.
  • Explore AI and digital tools for enhancing C&R process efficiency.

Benefits

  • Generous Paid Time Off (PTO) policy.
  • Defined Contribution Pension plan and Flex Dollars for retirement savings.
  • Stock purchase plan.
  • Education reimbursement program.
  • Comprehensive benefits through Philips Total Rewards.
Full Job Description
Titre du poste
Corrections & Removals Expert

Description de poste

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 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 Mississauga ON is $95,900 to $150,700 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, DC Pension, Flex Dollars (for SA/PSA/RRSP), 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 Mississauga ON.


#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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