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Regulatory Affairs Specialist I
4 months ago
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 affect the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.
We focus 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 to join our team.
Job Purpose
We currently have an open position for a Regulatory Affairs Specialist I. This position will be responsible for the production of documents and files such as standard regulatory submissions, annual reports, and general correspondence for submission to various regulatory agencies.
Job Responsibilities:
- Collects information and documentation for routine submissions to regulatory agencies.
- Seeks out related documentation as required to request agency approvals or in response to agency requests.
- Update basic information provided to various departments regarding submission requirements and standards to facilitate efficient processing by agency.
- Compiles and logs submissions that need review to ensure they meet regulatory submission standard policies, and operating procedure requirements.
- Gathers regulatory submissions to be reviewed for compliance and submission standards.
- Tracks through review process to ensure timely submission.
- Maintains effective relationships with internal customers.
- This is not an inclusive list of job responsibilities
Required Knowledge, Skills and Abilities:
- A Bachelor's degree in a scientific or technical discipline is required or equivalent work experience
- A minimum of one-two years Regulatory Affairs experience is required. One to three years Medical Industry experience is preferred
- Must have working knowledge of FDA and international regulations for regulatory submissions.
- 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.
Salary Range: $78k - $85k
#LI-LG1
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.
