Regulatory Affairs Specialist
The ideal candidate will have a deep understanding of regulatory requirements and standards for medical devices.
Job Description:
As a Regulatory Affairs Specialist, you will play a key role in ensuring compliance with regulatory requirements and standards for our medical devices. You will be responsible for coordinating and monitoring product registrations worldwide, creating technical product documentation, and organizing national adaptations of existing product registrations in case of product changes.
Responsibilities:
* Preparing and providing required documentation and deficiency responses to achieve medical device registrations internationally
* Providing reliable regulatory guidance in development projects
* Supporting sustaining engineering with regulatory inputs derived from norms, guidance docs, etc. throughout the life cycle of assigned devices
* Creating and maintaining device-specific STED documentation
* Providing input to achieve compliance with all regulatory requirements for assigned projects
* Monitoring policies to obtain up-to-date knowledge in quality and product relevant standards, laws and guidelines, with feedback into the department or organization as relevant
* Sustaining integration of a living Post Market Surveillance System at all locations, taking into account data flow from all hubs
* Supporting the quality team in product and process audits
Requirements:
* 3+ years of relevant work experience in a medical device company
* Previous proven experience in industry with requirements such as ISO 13485, MDR, QSR, 510k
* Self-driven, highly goal-oriented and independent personality
* Excellent interpersonal and communication skills, and ability to perform in a complex, global environment
* Excellent problem solving and negotiation skills
* Very good English language skills, other languages an asset
Benefits:
Our company offers a collaborative working environment with a lean hierarchy, open communication and high employee participation. We are always on the search for talented people looking to make a difference in the lives of millions of people with disabilities and functional impairments.
Why Work With Us?
We value dedication and make a real impact. Our business is growing, and we are always looking for talented individuals who share our vision to improve the functioning of millions of people with disabilities and functional impairments.