Senior Regulatory Affairs Lead — Medical Software

Medtronic plc; Parkmore; On-site; EUR 64,000 - 96,000; Full time

Job summary

Medtronic plc in Galway, Ireland, seeks a Senior Regulatory Affairs Specialist to lead software-based medical device submissions (FDA eSTAR) and EU Notified Body processes. You will craft regulatory strategies, liaise with cross-functional teams, and ensure compliance across global markets.

The role requires experience in preparing submissions, regulatory planning, and maintaining product files, with a focus on IEC 62304 and life-cycle processes.

Qualifications

• Prepare US and EU MDR submissions for new products and product changes.
• Review significant regulatory issues with the Manager and partners and resolve submission issues.
• Prepare regulatory strategies and worldwide compliance requirements.
• Provide ongoing support to project teams on regulatory issues and questions.
• Provide regulatory information to support development of regulatory strategies and requirements.
• Provide regulatory support for currently marketed products and documentation.
• Prepare submissions/reports for regulatory agencies as required.
• Maintain Regulatory Affairs product files and stay current on directives and standards.

Responsibilities

• Prepare submissions for US/EU regulatory approvals and maintain timelines.
• Review issues with supervisor and coordinate with engineering/partners.
• Develop and communicate regulatory strategies and plans for product portfolios.
• Support project teams with regulatory questions and documentation.
• Coordinate with Marketing and Global Supply Chain on regulatory needs.
• Maintain regulatory files to ensure ongoing compliance.

Skills

US/EU submissions

regulatory strategy

international agencies

regulatory analysis

regulatory documentation

stakeholder collaboration

maintain regulatory files

Job description

Medtronic plc in Galway, Ireland, seeks a Senior Regulatory Affairs Specialist to lead software-based medical device submissions (FDA eSTAR) and EU Notified Body processes. You will craft regulatory strategies, liaise with cross-functional teams, and ensure compliance across global markets.

The role requires experience in preparing submissions, regulatory planning, and maintaining product files, with a focus on IEC 62304 and life-cycle processes.