Getinge

Senior Quality & Compliance Specialist (US, Remote)

REMOTEPosted a month ago

Job summary

  • Job post source

    This job is directly from Getinge

  • Job overview

    The Senior Quality & Compliance Specialist at Getinge is responsible for managing medical device field actions and ensuring regulatory compliance to support life-saving technology accessibility.

  • Responsibilities and impact

    The role involves planning, reporting, and monitoring field actions, managing U.S. state licensing and registrations, coordinating compliance procedures, assisting with regulatory strategies and submissions, reviewing labeling and product changes, and supporting audits.

  • Compensation and benefits

    The position offers a base salary ranging from $102,800 to $130,000 plus a 10% short-term incentive plan (STIP).

  • Experience and skills

    Candidates need a bachelor's degree or equivalent experience, at least 5 years in medical device or pharmaceutical quality or regulatory roles, knowledge of FDA and international regulations, and strong communication and project management skills.

  • Work environment and culture

    Getinge values diversity, teamwork, forward thinking, and making a difference in healthcare through life-saving technology.

  • Company information

    Getinge is a global company with over 12,000 employees providing medical products and solutions in more than 135 countries, focused on improving clinical results and optimizing workflows.

  • Job location and travel

    This is a remote position based in the U.S.

  • Unique job features

    The role includes unique responsibilities such as managing worldwide field actions and recalls, and acting as a core team member in product development projects to ensure regulatory compliance.

Company overview

Getinge is a global medical technology company that provides equipment and systems within healthcare and life sciences. They specialize in products and solutions for surgery, intensive care, infection control, care ergonomics, and wound care. Founded in 1904 in Sweden, Getinge has grown through strategic acquisitions and innovations, making money by selling advanced medical devices and services to hospitals and healthcare providers worldwide. Their commitment to improving patient outcomes and hospital efficiency is a core aspect of their business model.

How to land this job

  • Position your resume to highlight your experience with medical device field actions, recalls, and compliance with FDA and international regulations, emphasizing your ability to manage multiple projects simultaneously.

  • Focus on showcasing your knowledge of regulatory affairs, product development processes, design control, and your skills in technical writing and communication, as these are critical for the Senior Quality & Compliance Specialist role at Getinge.

  • Apply through multiple channels including Getinge's corporate careers page and LinkedIn to maximize your visibility and chances of being noticed.

  • Connect with professionals in Getinge's regulatory affairs or quality compliance divisions on LinkedIn; start conversations by referencing recent regulatory challenges in the medical device industry or asking about their approach to global field actions and recalls.

  • Optimize your resume for ATS by incorporating keywords such as 'medical device field actions,' 'FDA regulations,' 'regulatory compliance,' 'product development,' and 'technical writing' to ensure it passes automated screenings.

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