Job title: Sr Regulatory Affairs Manager
Location: Mervue, Galway
Benefits: Top salary, bonus, pension, healthcare and car allowance



Overview:
As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products.


This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results through providing guidance and mentorship to team members, supporting their development and helping them navigate complex regulatory requirements.


Collaborate closely with cross-functional partners such as R&D, clinical, operations, and marketing to ensure regulatory needs are integrated into product development and lifecycle management. Occasionally represent the company in discussions with regulatory bodies and industry groups, supporting regulatory compliance and business objectives supporting Acute Care & Monitoring achieve regulatory success and maintain a competitive edge.



Role:

• Regulatory Strategy & Product Development: Support the development and implementation of global regulatory strategies throughout the product lifecycle, from R&D through commercialization and post-market activities. Collaborate with cross-functional teams to ensure regulatory requirements are incorporated into development plans and timelines. Provide regulatory guidance on product submissions (e.g., 510(k), etc.)
• Market Access & Submissions: Oversee the preparation, review and submission of regulatory filings in the US and EU. Liaise with regulatory bodies (e.g., FDA, Notified Body) to facilitate product approvals and resolve regulatory issues as needed
• Team Leadership & Development: Manage resources across assigned product programs, aligning activities with departmental priorities. Support team structure, talent development, and professional growth of regulatory staff. Mentor and coach team members to build regulatory expertise.
• Risk Management & Compliance: Identify potential regulatory risks and contribute to the development of mitigation strategies. Stay informed on evolving regulatory trends and changes, providing timely guidance to teams
• Business Initiatives: Participate in business initiatives by providing regulatory input and supporting due diligence for new ventures and partnerships.

• Level 8 Degree in Scientific or Engineering field with a minimum 7 year’s experience in regulatory affairs for medical devices of which 5+ years had leadership experience as demonstrated through direct management and/or mentorship/advisory capacity or an advanced degree with a minimum of 5+ year’s experience in regulatory affairs for medical devices with 5+ years had leadership experience as demonstrated through direct management and/or mentorship/advisory capacity direct management and/or mentorship/advisory capacity
• Leadership: Experience in a regulatory affairs leadership role, with a record of managing teams and supporting departmental goals
• Regulatory Affairs: Strong knowledge of the global regulatory landscape and experience interacting with regulatory bodies
• Product Lifecycle: Experience supporting medical devices from concept to market, including post-market activities