Program Manager -Field Actions CS (Remote US) - Defined Term

Maquet Cardiovascular-posted 8 months ago
$130,000 - $150,000/Yr
Full-time • Mid Level
Remote • Wayne, NJ
Computer and Electronic Product Manufacturing
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Responsible for planning, reporting, and monitoring medical device field actions (corrections/removals). Serve as the primary representative for the organization on committees and teams for activities supporting the Cardiovascular (CS) business. This is a defined term position for a one year term. Able to support the business during EST.

  • Serve as the point of contact for the Cardiovascular field action activities.
  • Provide work direction to junior staff members supporting field action activities.
  • Work with internal and external stakeholders to plan customer notifications and required internal and external reports within strict timelines for medical device field actions (corrections/removals).
  • Prepare and submit initial and monthly progress reports to regulatory authorities and internal stakeholders.
  • Ensure related customer notifications are complete, track customer responses and product returns or servicing, as applicable.
  • Ensure related corrective and preventative actions are completed as planned.
  • Obtain updates for related complaints and vigilance reports.
  • Confirm proper disposition/destruction of returned/quarantined affected product.
  • Notify international colleagues of field actions and provide them with the documentation they need for their local/regional activities.
  • Keep track of their progress.
  • Respond to internal and external inquiries.
  • Work with other functions (for example, Quality, Regulatory Affairs, Medical Affairs, Complaints, Customer Service, Sales Support, Service, etc.) as needed to prepare such responses.
  • Support management reviews and internal/external audits and inspections with respect to field actions.
  • Stay current on changes to global regulatory requirements and industry standards related to medical device field actions.
  • Provide input for and/or review departmental procedures, work instructions, templates, and guidance.
  • Develop and maintain positive relationships with U.S. FDA, EU Notified Body, and global regulatory agencies through oral and written communications related to field actions.
  • Assist with the training and mentoring of staff.
  • Identify and participate in department/systems development and improvement initiatives.
  • Other responsibilities as assigned.
  • A Bachelor's degree in a scientific or technical discipline or equivalent work experience. Advanced degree preferred.
  • A minimum of 6 years of experience with medical devices or pharmaceuticals in a Quality, Regulatory Affairs, or Regulatory Compliance role.
  • Three or more years prior experience with field actions and/or complaints and vigilance is preferred.
  • Program Management experience in Quality function.
  • Advanced knowledge of Quality Management System operations and application of Regulations, ISO standards, and management controls.
  • Experience with post-market quality activities - recalls/field actions, CAPA, complaint handling, corrections and removals.
  • Experience with FDA and/or Notified Body audits/inspections.
  • Proficiency with Microsoft Office Suite - MS Word, Excel, PowerPoint, Outlook, and Teams.
  • Exceptional verbal, written, and presentation skills.
  • Excellent time management skills, ability to work independently, self-motivated, and highly accountable for deliverables and timelines.
  • Detail-oriented, highly organized, and performs work with a high degree of accuracy.
  • Effective problem-solving capabilities, solution-oriented with the ability to understand, review, and communicate complex technical concepts concisely and accurately.
  • Promotes successful teamwork and morale.
  • Remote Work: 3-5 days
  • Salary Range: minimum of $130,000 and a maximum of $150,000
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