About the Role:
We are seeking a highly skilled and motivated Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs group, you will be responsible for providing strategic guidance on regulatory issues and ensuring compliance with relevant laws and regulations.
Responsibilities:
* Develop, update, and execute US and Canada registration strategies
* Provide input to clinical programs to support market differentiation needs
* Support development and update of labeling strategies to deliver market differentiation
* Develop and update US and CA labeling, including prescribing information, patient labeling, device labeling (IFU) for new products and indications
* Liaison with product and clinical development teams and liaison with diagnostic development experts
* Liaison with global marketing/NPP/VEO/Payer functions/US Brand Teams
* Own relationship and interaction strategy with US and Canada regulatory authorities
Requirements:
* Bachelor's degree in scientific or health sciences discipline
* Industry-related experience in regulatory affairs and/or drug development experience for minimum of 5-8 years
What We Offer:
* A competitive salary and benefits package
* Ongoing training and development opportunities
* A collaborative and dynamic work environment
About Us:
We are a global healthcare leader dedicated to helping individuals with disabilities actively engage in the workforce. We offer equal opportunities to all applicants and employees.