Regulatory Affairs Director
The Regulatory Affairs Director will play a pivotal role in leading and overseeing all regulatory compliance activities for a fast-growing medical device company based in the West of Ireland. This leadership position will define and execute regulatory strategies in support of new product development and post-market activities.
Key Responsibilities:
* Develop and implement regulatory frameworks for new product introductions and existing products through their full lifecycle.
* Manage regulatory submissions, including 510(k) and CE Mark, and global product registrations.
* Act as primary liaison for regulatory agencies, including US and European authorities.
* Monitor and interpret evolving regulatory requirements to ensure company compliance.
* Collaborate 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.
* Provide strategic advice and cross-functional support on all regulatory matters.
Requirements:
* Bachelor's degree in Engineering, Life Sciences, or a health-related field.
* 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
* In-depth knowledge of US FDA and EU medical device regulations.
* Proven ability to handle complex regulatory submissions and interactions.
* Excellent organizational, leadership, and communication skills.
* A self-starter with a hands-on approach and the ability to thrive in a dynamic environment.