Regulatory Affairs Associate: Submissions & Compliance

infusion.fi; Tempe (AZ); On-site; USD 95,000 - 125,000; Full time

Job summary

BD is hiring a Regulatory Affairs professional in Tempe, AZ to ensure US and CE Mark regulatory compliance and to support global notifications. You will work with product teams, prepare documentation, and assist in audits.

The role involves maintaining databases, interpreting data, and coordinating with regional groups. Up to 25% travel may be required to support regulatory activities.

Qualifications

• Degree level qualification or equivalent.
• Ability to plan and schedule multiple priorities.
• Ability to review, collate and summarize scientific data.

Responsibilities

• Review regulatory changes to ensure US and CE Mark compliance.
• Prepare notifications and communicate changes to global regions.
• Support core teams with regulatory requirements and audits.
• Maintain regulatory databases and provide data interpretation.
• Travel up to 25% to support regulatory functions.

Skills

Regulatory affairs

Documentation writing

Data interpretation

Project management

Cross-functional collaboration

Education

Degree level qualification

Job description

BD is hiring a Regulatory Affairs professional in Tempe, AZ to ensure US and CE Mark regulatory compliance and to support global notifications. You will work with product teams, prepare documentation, and assist in audits.

The role involves maintaining databases, interpreting data, and coordinating with regional groups. Up to 25% travel may be required to support regulatory activities.