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Regulatory affairs specialist

Gort
Natus
Regulatory affairs specialist
Posted: 27 January
Offer description

FOR MORE THAN 80 YEARS, Natus has been committed to serving the varying needs of clinicians, delivering the highest-quality solutions to raise the standard of care for patients everywhere.

Our comprehensive diagnostic and therapeutic sensory solutions are designed to simplify workflows for sensory specialists, ensuring care teams have the right instrumentation to give patients the right support — and greater peace of mind.


Job Function: Quality Assurance & Regulatory



Job Family: Regulatory Affairs





Job Overview:



Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.





Responsibilities:



This entry-level professional role is focused on learning to apply formal training and foundational professional concepts to assigned tasks. The position involves gaining familiarity with standard problem-solving methodologies and learning to recognize and escalate issues or abnormalities to more experienced staff before acting on solutions.



The role requires clear and effective communication with coworkers, as well as active listening and the ability to provide factual responses. Project assignments are typically defined by others, and work is reviewed frequently to ensure alignment with expectations.



While independent responsibility is minimal, the individual is expected to contribute as a member of a team and begin developing basic work planning skills. Timely communication with leadership regarding potential delays or issues is essential. This role is designed to provide foundational experience and support professional growth in a structured environment.



Contribute to the team's success by embracing our guiding principles and behaviors and actively participating in a culture that puts our Patient first.  You will demonstrate exceptional teamwork, agility, accountability, and respect, cultivating an environment where collaboration and continuous improvement thrive.





Experience Required:



This level is intended for individuals beginning their professional careers or transitioning into a new field. Candidates are expected to have recently completed formal education or training relevant to the role. No or limited prior professional experience may be required, though internships or academic projects may be beneficial. The role focuses on learning core concepts, following structured guidance, and developing the skills needed to perform assigned tasks reliably with support and oversight.



Compensation and Benefits: Along with a competitive salary and bonus structure, we offer a comprehensive benefit package to start: Health & Life Assurance cover, defined contribution pension plan, active sports and social club, flexible work location, flextime (depending on position), excellent career progression opportunities, free parking, and educational assistance.

Join Natus Sensory today. Confidence in every Sense.



EEO Statement: Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

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