Senior Regulatory Affairs for SaMD Submissions (Hybrid)

Medtronic plc; Galway; Híbrido; EUR 64 000 - 96 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Flexible benefits package

Resumo da oferta

Medtronic plc, Galway, Ireland, is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for software-based medical devices. You will interact with FDA/EU authorities, develop global regulatory strategies, and guide cross-functional teams through the product lifecycle.

The role requires 4+ years in medical device regulation, strong knowledge of IEC 62304, ISO 13485, and real-world experience with SaMD/SiMD. Hybrid work in Ireland with a competitive benefits package.

Qualificações

• Minimum NFQ level 8 Bachelor’s degree in a technical discipline with a minimum of 4 years of medical device regulatory experience or with an Advanced/Master’s degree with a minimum of 2 years of medical device regulatory experience.
• Experience with regulatory submissions and interactions with agencies such as FDA and PMDA.
• In-depth experience with FDA requirements, EU MDR, IEC 62304, ISO 14971/13485 and global regulatory standards.
• Knowledge of SaMD/SiMD and ability to apply regulatory principles.
• Strong written and oral communication, negotiation, and teamwork skills.

Responsabilidades

• Prepare US and EU MDR submissions for new products and changes to support timely market release.
• Develop regulatory strategies and plans and support project teams on regulatory issues.
• Provide regulatory support for marketed products, including labeling reviews and documentation.
• Maintain regulatory product files and comply with global regulatory requirements.
• Engage with regulators and coordinate cross-functional teams to meet deadlines.
• Assist in planning regulatory strategies, target markets, and distribution methods.

Conhecimentos

Regulatory submissions

Regulatory strategy

Negotiation

Project management

SaMD/SiMD knowledge

IEC 62304

ISO 13485/Quality standards

Cross-functional collaboration

Regulatory agency liaison

Formação académica

Bachelor’s degree (NFQ 8) in technical discipline

Ferramentas

Microsoft Office

Microsoft Project

Adobe Acrobat

Agile

Descrição da oferta de emprego

Medtronic plc, Galway, Ireland, is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for software-based medical devices. You will interact with FDA/EU authorities, develop global regulatory strategies, and guide cross-functional teams through the product lifecycle.

The role requires 4+ years in medical device regulation, strong knowledge of IEC 62304, ISO 13485, and real-world experience with SaMD/SiMD. Hybrid work in Ireland with a competitive benefits package.