Regulatory Affairs Specialist I

Getinge•Fraser, MI

3d•Hybrid

About The Position

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.

Requirements

Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment.
Ability to represent Regulatory Affairs to other departments.
Working knowledge of principle compliance focused ISO Standards and the use of ISO Standards as special controls.
Bachelor's Degree in Scientific/Engineering discipline or equivalent work experience in a regulated industry.
Understands the requirements of FDA 21CFR Part 820 QMSR, EU MDR, MDSAP, CMDR and ISO 13485.
Proficient computer skills, including Adobe Professional and MS Office applications (Word/Excel) are required.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
Attend all required Quality & Compliance training at the specified interval.
Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

Responsibilities

Collect 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.
Communicate application progress to internal stakeholders.
Collaborate with worldwide colleagues regarding product registration, license renewals and updates.
Maintain regulatory files and tracking databases as required.
Tracks through review process to ensure timely submission.
Support with Field Correction and Recall activities.
Participate in and support internal and third-party audits.
Supports with the documentation and activities related to EU MDR, PMA, and 510(k) submissions when required.
Communicate with regulatory agencies as needed.
Contributes to team effort by accomplishing related duties as requested.
Assists in special projects as needed.