Regulatory Affairs Associate – MedTech

Medtronic plc; Memphis, Northern (TN, KY); Hybrid; USD 61,000 - 91,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) with company contribution

Tuition assistance

Job summary

Medtronic plc in Memphis, TN seeks an Associate Regulatory Affairs Specialist to coordinate regulatory submissions and manage documentation for the Cranial and Spinal Technologies portfolio. This on-site role supports submissions, audits, and labeling updates to ensure compliance across US and international regimes.

The position requires a Bachelor's degree and 1+ year in Regulatory Affairs or related fields, with strong MS Office skills and familiarity with regulatory management systems.

Qualifications

• Bachelor's degree required.
• 1+ year in Regulatory Affairs, Quality, Clinical, or related regulated field.
• Knowledge of US and international regulatory requirements.

Responsibilities

• Coordinate regulatory submission packages and supporting documentation.
• Gather materials for submissions, renewals, and related filings.
• Support audits, inspections, and regulatory inquiries with organized documentation.
• Review labeling and manufacturing documentation for regulatory compliance.
• Maintain tracking systems for submissions, commitments, and approvals.
• Monitor regulatory guidance and changes to support compliance.

Skills

Regulatory submissions experience

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree

Tools

Microsoft Office

Regulatory information management systems

Document control systems

Job description

Medtronic plc in Memphis, TN seeks an Associate Regulatory Affairs Specialist to coordinate regulatory submissions and manage documentation for the Cranial and Spinal Technologies portfolio. This on-site role supports submissions, audits, and labeling updates to ensure compliance across US and international regimes.

The position requires a Bachelor's degree and 1+ year in Regulatory Affairs or related fields, with strong MS Office skills and familiarity with regulatory management systems.