Medical Device QA Investigator - Regulatory & Post-Market

Hologic, Inc.; Marlborough (MA); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA is seeking a Clinical QA Specialist to lead investigation and reporting of adverse events and regulatory submissions.

You will partner with Technical Service, Regulatory, Marketing, and Sales to ensure timely, accurate documentation and compliant communications. The role emphasizes risk management, CAPAs, and post-market surveillance to safeguard patient safety and product quality.

Qualifications

• Bachelor’s degree in Medicine, Nursing, Biomedical Engineering, or a related field.
• 5+ years of experience in a similar clinical QA/regulatory role.
• Hands-on experience with adverse event reporting and regulatory communications.

Responsibilities

• Investigate and report adverse events and other regulatory submissions.
• Collaborate with Technical Service, Regulatory, Marketing, and Sales teams.
• Ensure timely and thorough documentation and communication.
• Lead or participate in internal and external audits and inspections.

Skills

Adverse event analysis

Regulatory communications

Cross-functional collaboration

Documentation & reporting

Audit participation

Process improvement

Attention to detail

Education

Bachelor’s degree in Medicine / Nursing / Biomedical Engineering

Job description

Hologic, Inc. in Marlborough, MA is seeking a Clinical QA Specialist to lead investigation and reporting of adverse events and regulatory submissions.

You will partner with Technical Service, Regulatory, Marketing, and Sales to ensure timely, accurate documentation and compliant communications. The role emphasizes risk management, CAPAs, and post-market surveillance to safeguard patient safety and product quality.