Regulatory Compliance Leader
This role will oversee all regulatory compliance activities for a medical device company. The successful candidate will lead and develop strategies for new product introductions, manage regulatory submissions, and act as primary contact for regulatory agencies.
* Develop and execute regulatory strategies for new product introductions and post-market activities.
* Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations.
* Act as primary contact for regulatory agencies, including US and European authorities.
* Monitor and interpret evolving regulatory requirements to ensure company compliance.
* Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
* Review and approve promotional and advertising materials from a regulatory perspective.
* Identify and allocate internal and external resources needed to maintain a robust regulatory function.
Candidate Requirements:
* Bachelor's degree in Engineering, Life Sciences, or health-related field.
* 10+ years of experience in the medical device industry, with 3+ years in leadership or management.
* In-depth knowledge of US FDA and EU medical device regulations (including MDR).
* Proven ability to handle complex regulatory submissions and interactions.
* Excellent organizational, leadership, and communication skills.
* A self-starter with hands-on approach and ability to thrive in dynamic environment.