Regulatory Affairs Specialist: Accelerate Device Approvals

Stryker Group; Cork; On-site; EUR 42,000 - 71,000; Full time

Job summary

Stryker Ireland is seeking a Regulatory Affairs Specialist to support bringing medical devices to market and maintaining ongoing regulatory compliance. You will work under supervision and collaborate with cross-functional teams to develop global regulatory strategies, author submissions, and interact with regulators.

The role focuses on US, EU, and international regulatory requirements, including labeling review and change assessment, with opportunities to contribute to post-market activities

Qualifications

• Bachelor’s degree in an Engineering, Science, or equivalent field.
• 1-2 years in a Regulatory Affairs role.

Responsibilities

• Learn and develop regulatory skills to bring medical devices to market and ensure ongoing compliance.
• Participate in New Product Development to incorporate US, EU, and other international regulatory requirements.
• Author regulatory submissions and interact with regulatory agencies/notified bodies.

Skills

Regulatory knowledge

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Science, or equivalent

Job description

Stryker Ireland is seeking a Regulatory Affairs Specialist to support bringing medical devices to market and maintaining ongoing regulatory compliance. You will work under supervision and collaborate with cross-functional teams to develop global regulatory strategies, author submissions, and interact with regulators.

The role focuses on US, EU, and international regulatory requirements, including labeling review and change assessment, with opportunities to contribute to post-market activities