Senior Quality & Compliance Specialist (US, Remote)

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview The Sr. Quality and Compliance Specialist is responsible for planning, reporting, and monitoring medical device field actions (corrections/removals). Job Responsibilities and Essential Duties

• Ensure customer notifications are completed according to the timelines established in the Global Field Action Plan; ensure compliance with global regulations and/or laws.
• Responsible for U.S. State Drug and Medical Device Licensing, Establishment Registrations, Device Listings (50 States)
• Responsible for World-wide Field Actions and Recalls (Monthly Reports, Effectiveness Checks)
• Coordinates all procedures, training and systems to ensure compliance to regulatory processes for all Getinge products sold in the U.S.
• Assists with developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow‑up of submissions under review.
• Assists with developing and implementing regulatory strategies for new and modified medical devices.
• Acts as a core team member on -project teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Responsible for preparation and submission of routine regulatory applications, as well as internal regulatory file documentation.
• Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Provides supports for internal and external audits.
• This is not an inclusive list of job responsibilities.

Minimum Requirements

• A Bachelor’s degree in a scientific or technical discipline is required or equivalent work experience.
• A minimum of 5 years of experience with medical devices or pharmaceuticals in a Quality, Regulatory Affairs, or Regulatory Compliance role is required.
• Prior experience with medical device field actions and/or complaints and vigilance is preferred.

Required Knowledge, Skills and Abilities

• Must have working knowledge of FDA and international regulations.
• Must have general understanding of product development process and design control
• Must have general understanding of regulations applicable to the conduct of world-wide recalls and field actions.
• Must be able to manage several projects.
• Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications is preferred.
• Must demonstrate effective research and analytical skills.
• Must demonstrate effective written and verbal communication, including technical writing skills.
• Must be able to work independently with minimal supervision.

The base salary for this position is a minimum of $102,800 and a maximum of $130,000, plus 10% STIP About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process. Apply Job! Apply to this Job