Medical Device Compliance Specialist

7 days ago

Galway, Galway, Ireland beBeeRegulatory Full time €100,000 - €140,000

Job Title: Regulatory Affairs Professional

We are seeking a highly motivated and experienced Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities.

This key position will be responsible for leading the regulatory strategy for new product introductions and support existing products through their full lifecycle. You will manage regulatory submissions (e.g. 510(k), CE Mark) and global product registrations, act as the primary contact for regulatory agencies, monitor and interpret evolving regulatory requirements and apply them to ensure company compliance, and review and approve promotional and advertising materials from a regulatory perspective.

The ideal candidate will have a bachelor's degree in Engineering, Life Sciences, or a health-related field, with at least 10 years of experience in the medical device industry, including 3+ years in a leadership or management role. In-depth knowledge of US FDA and EU medical device regulations is required, as well as proven ability to handle complex regulatory submissions and interactions. Excellent organizational, leadership, and communication skills are essential.

If you are a self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment, we encourage you to apply for this challenging opportunity.

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