Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Wayne, New Jersey
Together we can make a difference
At Getinge we are dedicated and passionate about helping our customers save lives and ensure excellent care. A career at Getinge provides career opportunities that both inspire and challenge. Here, you can make a difference every day.
Position Responsibilities: (Key responsibilities, authorities, and inter-relationships)
* Collects information and documentation for routine submissions to regualtory agencies.
* Seeks out related documentation as required to request agency aprovals 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 requriements.
* 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.
· Minimum Requirements:
* A Bachelor's degree in a scientific or technical discipline is required or equivalent work experience.
* One to two years Regulatory Affairs experience is preferred. Medical Industry experience is highly desirable.
* Working knowledge of FDA and international regulations is preferred.
* Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications is preferred.
* Must demonstrate strong analytical skills.
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Getinge Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.
We look forward to receiving your application.