Senior Electrical Engineer
Galway
Permanent
As Senior Manager of Regulatory Affairs, you will play a key leadership role within the Acute Care & Monitoring (ACM) function, supporting regulatory activities across a diverse product portfolio.
This role involves developing and executing regulatory strategies, overseeing regulatory submissions, assessing the regulatory impact of product changes, and ensuring the delivery of high-quality regulatory outcomes. You will provide leadership, guidance, and mentorship to regulatory team members, supporting their professional development and helping them navigate complex regulatory requirements.
You will collaborate closely with cross-functional partners including R&D, clinical, operations, and marketing to ensure regulatory requirements are fully integrated into product development and lifecycle management. From time to time, you will represent the organisation in discussions with regulatory authorities and industry groups, supporting regulatory compliance while enabling business objectives and maintaining a competitive edge in the Acute Care & Monitoring sector.
A Day in the Life
Regulatory Strategy & Product Development
This role involves developing and executing regulatory strategies, overseeing regulatory submissions, assessing the regulatory impact of product changes, and ensuring the delivery of high-quality regulatory outcomes. You will provide leadership, guidance, and mentorship to regulatory team members, supporting their professional development and helping them navigate complex regulatory requirements.
You will collaborate closely with cross-functional partners including R&D, clinical, operations, and marketing to ensure regulatory requirements are fully integrated into product development and lifecycle management. From time to time, you will represent the organisation in discussions with regulatory authorities and industry groups, supporting regulatory compliance while enabling business objectives and maintaining a competitive edge in the Acute Care & Monitoring sector.
A Day in the Life
Regulatory Strategy & Product Development
- Support the development and implementation of global regulatory strategies across the full product lifecycle, from R&D through commercialisation and post-market activities
- Collaborate with cross-functional teams to ensure regulatory requirements are embedded in development plans and timelines
- Provide regulatory guidance on product submissions (e.g. 510(k) and similar pathways)
- Oversee the preparation, review, and submission of regulatory filings in the US and EU
- Liaise with regulatory authorities (e.g. FDA, Notified Bodies) to facilitate approvals and resolve regulatory issues
- Manage regulatory resources across assigned product programmes, aligning activities with departmental priorities
- Support team structure, talent development, and professional growth
- Mentor and coach team members to build regulatory expertise and leadership capability
- Identify potential regulatory risks and contribute to the development of mitigation strategies
- Stay informed of evolving regulatory requirements and trends, providing timely guidance to teams
- Contribute regulatory expertise to business initiatives, including due diligence for new ventures and partnerships
- Level 8 degree in a scientific or engineering discipline with a minimum of 7 years’ experience in medical device regulatory affairs, including 5+ years in a leadership role (direct management and/or mentorship),
- An advanced degree with a minimum of 5 years’ experience in medical device regulatory affairs, including 5+ years in a leadership role
- Proven leadership experience within regulatory affairs, with a track record of managing teams and supporting departmental goals
- Strong knowledge of the global regulatory landscape and experience interacting with regulatory authorities
- Experience supporting medical devices across the full product lifecycle, including post-market activities
- Strong business acumen with an understanding of operations and financial considerations in a regulated environment
- Demonstrated ability to support process improvement and change management initiatives
- Ability to use data and analytics to support decision-making and clearly communicate regulatory requirements
- Excellent communication, interpersonal, and influencing skills, with the ability to collaborate cross-functionally and represent the organisation externally
