Clinical QA & Post-Market Surveillance Specialist

DIRECT SALES, US; Newark (DE); On-site; USD 85,000 - 133,000; Full time

Job summary

Hologic is seeking a Clinical QA Specialist to investigate and report adverse events and manage regulatory reporting activities. The role collaborates with Technical Service, Marketing, Sales, and Regulatory to ensure timely documentation and thorough analysis.

Candidates should have a strong regulatory compliance and quality assurance background in medical devices, with 5+ years of relevant experience. The position offers a competitive base salary and bonus eligibility.

Qualifications

• Bachelor’s degree in a medical/engineering field or related discipline; Risk Managers considered.
• 5+ years in a similar clinical QA/regulatory role in medical devices or healthcare.
• Hands-on adverse event reporting, regulatory communications, and health risk assessments.
• Proven track record in supporting or leading CAPAs, nonconformances, and investigations.

Responsibilities

• Investigate and report potential and actual adverse events.
• Collaborate with cross-functional teams to document, analyze, and report regulatory information.
• Lead or participate in audits, inspections, and quality system activities.

Skills

Adverse event analysis

Communication with regulators

CAPA investigations

Nonconformances handling

Quality investigations

Metrics & reporting

Process improvement

Audit support

Education

Bachelor’s degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering or related field

Job description

Hologic is seeking a Clinical QA Specialist to investigate and report adverse events and manage regulatory reporting activities. The role collaborates with Technical Service, Marketing, Sales, and Regulatory to ensure timely documentation and thorough analysis.

Candidates should have a strong regulatory compliance and quality assurance background in medical devices, with 5+ years of relevant experience. The position offers a competitive base salary and bonus eligibility.