Job Title: Regulatory Affairs Specialist
We are seeking a seasoned Regulatory Affairs professional to join our team. In this role, you will be responsible for coordinating and monitoring product registrations worldwide.
Responsibilities
* Develop and implement regulatory strategies for medical device products
* Ensure compliance with international regulations and standards
* Collaborate with cross-functional teams to achieve product registrations
* Maintain accurate and up-to-date technical documentation
* Provide regulatory guidance to development projects
* Support sustaining engineering with regulatory inputs throughout the product lifecycle
The ideal candidate will have a Bachelor's degree in engineering or science, over 3 years of relevant experience in a medical device company, and proven experience with ISO 13485, MDR, QSR, and 510k.
Key qualities include self-motivation, goal-orientation, and independence, as well as excellent interpersonal and communication skills.
Requirements
* Bachelor's degree in engineering or science
* Over 3 years of relevant experience in a medical device company
* Proven experience with ISO 13485, MDR, QSR, 510k
This is an exciting opportunity to join a global network committed to redefining rehabilitation therapy standards.