Senior Compliance Leader: FDA/ISO QA

BioCT Innovation Commons; North Haven (CT); On-site; USD 90,000 - 134,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

401(k) with employer match

Paid Time Off

Tuition assistance

Job summary

Medtronic in North Haven, CT is seeking a Senior Quality & Regulatory professional to lead investigations, root-cause analysis, and corrective actions across global medical device compliance programs. You will provide Quality System support, oversee audits, and ensure adherence to FDA, ISO 13485, GMP, and MDSAP standards while coordinating with global stakeholders.

The role requires strong communication, data analysis, and project leadership, with travel up to 25% and a focus on continuous

Qualifications

• Knowledge of FDA, GMP, QSR and ISO 13485, and MDSAP requirements.
• Experience implementing and communicating regulatory requirements in healthcare.
• Experience leading audits and maintaining quality systems.

Responsibilities

• Own investigations, root cause analyses and corrective actions.
• Provide Quality System support to ensure regulatory compliance.
• Lead and/or participate in internal and external audits.
• Support regulatory inspections and audits across entities.
• Perform trend analyses and communicate improvements.
• Coordinate with stakeholders to drive compliance initiatives.

Skills

Root cause analysis

Regulatory compliance

Quality investigations

Data analysis

Audits & inspections

Leadership

Communication

Education

Bachelor’s degree

Advanced degree

Job description

Medtronic in North Haven, CT is seeking a Senior Quality & Regulatory professional to lead investigations, root-cause analysis, and corrective actions across global medical device compliance programs. You will provide Quality System support, oversee audits, and ensure adherence to FDA, ISO 13485, GMP, and MDSAP standards while coordinating with global stakeholders.

The role requires strong communication, data analysis, and project leadership, with travel up to 25% and a focus on continuous