Post-Market Analytics & Surveillance Specialist

Mallinckrodt Pharmaceuticals; Bridgewater (MA); Hybrid; USD 61,000 - 98,000; Full time

Benefits offered by this job

Total Rewards package

Bonus eligibility

Job summary

Keenova is hiring a Post Market Surveillance Specialist to support product monitoring, complaint trending, and regulatory reporting. You will analyze data, prepare metrics, and collaborate across R&D, Quality, and Operations to ensure compliance and continuous improvement.

Hybrid/onsite role with a focus on cross-functional teamwork and timely, accurate reporting. A Bachelor’s degree with 4+ years in medical devices/pharma is required; a bonus program may apply.

Qualifications

• Bachelor's degree in Science, Engineering, Mathematics, Business, or a related discipline.
• Minimum 4 years of experience in medical device, biologics, and/or pharmaceutical manufacturing.
• Minimum 1 year of experience performing data analysis and trending activities.
• Experience with complaint management and post-market surveillance preferred.

Responsibilities

• Perform quality metrics and trending analyses for complaint data.
• Prepare, analyze, and present complaint trending data, product performance metrics, and post-market surveillance information.
• Escalate identified complaint trends, safety signals, or Drug-1 complaints.
• Complete literature reviews to identify potential quality complaints or safety information.
• Support product recall activities and regulatory documentation.
• Initiate document changes and revise SOPs and related quality documents.
• Collaborate with R&D, Engineering, Quality, Operations, Medical Affairs, and others to evaluate data.
• Generate, maintain, and distribute reports, scorecards, dashboards, and surveillance metrics.
• Support audits and regulatory inspections; assist with responses.

Skills

Excel (Advanced)

Power BI

Microsoft Word

PowerPoint

Data analysis

Communication

Education

Bachelor's degree in Science/Engineering/Math/Business

Tools

Power BI

Job description

Keenova is hiring a Post Market Surveillance Specialist to support product monitoring, complaint trending, and regulatory reporting. You will analyze data, prepare metrics, and collaborate across R&D, Quality, and Operations to ensure compliance and continuous improvement.

Hybrid/onsite role with a focus on cross-functional teamwork and timely, accurate reporting. A Bachelor’s degree with 4+ years in medical devices/pharma is required; a bonus program may apply.