Job Summary
We are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities for our company in Galway, Ireland.
Main Responsibilities:
* Strategic Compliance: Define and execute regulatory strategies in support of new product development and post-market activities.
* Submission Management: Manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations.
* Regulatory Agency Liaison: Act as the primary contact for regulatory agencies, including authorities in the U.S. and Europe.
* Compliance Monitoring: Monitor and interpret evolving regulatory requirements and apply them to ensure company compliance.
* Vigilance and Post-Market Surveillance: Partner with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
* Regulatory Review: Review and approve promotional and advertising materials from a regulatory perspective.
* Resource Allocation: Identify and allocate internal and external resources needed to maintain a robust regulatory function.
Requirements:
* A degree in Engineering, Life Sciences, or a health-related field.
* At least 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 (including MDR).
* A 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. Previous experience in an SME or medtech startup is highly desirable.