Senior Regulatory & Quality Compliance Lead

Medtronic; North Haven (CT); On-site; USD 110,000 - 160,000; Full time

Job summary

Medtronic in North Haven, CT is seeking a QA Compliance professional to lead investigations, perform root cause analysis, and drive CAPAs. You will provide Quality System support to ensure FDA and ISO regulatory compliance, and oversee QMS programs across global sites.

The role requires extensive regulatory knowledge, strong communication, and the ability to coordinate audits, data analysis, and cross-functional collaboration with a focus on continuous improvement.

Qualifications

• Bachelor's degree required.
• Minimum 6 years of relevant experience, or 4 years with advanced degree.
• Knowledge of FDA, GMP, QSR, ISO 13485, and MDSAP for finished medical devices.
• Experience with Core QMS, Design Control & Manufacturing processes.
• Ability to analyze data and identify risks and root causes.
• Excellent written, oral communication and presentation skills.
• Ability to manage multiple critical projects.

Responsibilities

• Own and drive investigations, root cause analysis, and CAPAs.
• Provide Quality System support to maintain regulatory compliance.
• Oversee development and maintenance of quality systems, programs, processes, and procedures.
• Support EU Surgical Operating Unit with QMS setup, audits, and certifications.
• Partner with stakeholders to drive compliance program execution.
• Communicate business issues or opportunities to management.
• Lead audits per regulatory standards (FDA and equivalents).
• Perform trend analyses and report observations for improvement.
• Investigate and resolve compliance questions and complaints.
• Maintain knowledge of FDA, HIPAA and ISO requirements through policies.
• Demonstrate writing/editing skills in communications and reports.

Skills

Excellent writing and editing skills

Strong communication skills

Leadership abilities

Data analysis skills

Problem-solving skills

Regulatory knowledge

Education

Bachelor's Degree

Job description

Medtronic in North Haven, CT is seeking a QA Compliance professional to lead investigations, perform root cause analysis, and drive CAPAs. You will provide Quality System support to ensure FDA and ISO regulatory compliance, and oversee QMS programs across global sites.

The role requires extensive regulatory knowledge, strong communication, and the ability to coordinate audits, data analysis, and cross-functional collaboration with a focus on continuous improvement.