About the role
Job Title: Analyst, Product Surveillance
Location: Burlington, MA (100% Onsite)
Job Summary
Abbott is seeking an experienced Analyst, Product Surveillance II (Sr. Quality Specialist) to support product quality and regulatory compliance activities. The ideal candidate will have experience in complaint handling, medical writing, regulatory compliance, data analysis, and cross-functional collaboration within the medical device, pharmaceutical, or healthcare industry.
Key Responsibilities
- Manage and investigate product complaints while ensuring regulatory compliance.
- Prepare and review medical and quality documentation.
- Analyze quality data using Excel and Power BI to identify trends and support decision-making.
- Collaborate with Quality, Regulatory, Engineering, and other cross-functional teams.
- Drive continuous improvement initiatives and support quality projects.
- Ensure compliance with FDA and global regulatory requirements.
- Provide technical support and may lead quality-related projects.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, or a related field .
- 4+ years of experience in Quality, Product Surveillance, or a related field .
- Experience in the Medical Device, Pharmaceutical, or Healthcare industry.
- Strong knowledge of complaint handling, medical writing, quality systems, and regulatory compliance .
- Proficiency in Microsoft Excel ; experience with Power BI is preferred.
- Excellent analytical, problem-solving, and communication skills.
Millions of jobs, with real people getting hired every day
Questions, answered
Click "Apply with JobAssist" – we tailor your resume and application to this role and submit it for your approval.
Yes. This role at Intellectt Inc was screened before publishing – we confirmed the employer before listing it.
The employer didn't disclose a salary range for this listing. JobAssist shows pay whenever it's available.
This position can be done from anywhere, with no in-office requirement.
Yes – every application is tailored from your profile and this job's requirements, and you can review and edit before it's sent.