Regulatory Affairs Specialist II

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.

Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

We currently have an opening for a Regulatory Affairs Specialist II. This position is responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process.

Job Functions

• 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 development 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.
• This is not an inclusive list of job responsibilities.
  
  

Required

Required Knowledge, Skills and Abilities:

• A Bachelor’s degree in a scientific or technical discipline is required or equivalent work experience
• A minimum of two years Regulatory Affairs experience is required. Two to four years Medical Industry experience is preferred.
• 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.
  
  

Salary range: $95k-$110k

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.