Job Title: Senior Director, Regional Regulatory Affairs
About the Job
At a pioneering medical device company, we are revolutionizing cancer care with Tumor Treating Fields (TTFields) therapy, a cutting-edge, non-invasive approach that's changing lives.
We're a dynamic organization with the drive of a startup and the strength of years of success.
Key Responsibilities:
* Develop and lead regional regulatory strategies aligned with global business goals and product development timelines.
* Review registration and submit to regional regulatory authorities and participate in key agency interactions and negotiations.
Compliance & Risk Management:
* Monitor and interpret evolving regional regulatory requirements and communicate changes to internal stakeholders.
* Ensure regulatory compliance of labeling, advertising, promotional materials, and product changes to meet regional requirements.
Team Management & Development:
* Lead and develop a high-performing regional regulatory team.
* Mentor and coach staff to support career development and performance excellence.
Cross-functional Collaboration:
* Collaborate with R&D, Clinical Affairs, Quality Assurance, Legal, Marketing, and Commercial teams to ensure regulatory alignment and support business priorities.
* Provide regulatory input into business development and due diligence activities.
Required Skills:
* Bachelor's degree in a scientific discipline; advanced degree (MS, PhD, or equivalent) preferred.
* 15+ years of regulatory affairs experience in the medical device industry, with at least 8 years in a leadership capacity.
* Proven track record of successful Class III medical device submissions and approvals in the designated region.
Benefits:
Our company offers a comprehensive benefits package, including competitive remuneration, professional development opportunities, and a collaborative work environment.