About ECI 

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. 

About The Role 

As Post Market Surveillance Senior Complaints Specialist you will be responsible for investigating, documenting and closing out customer complaints regarding medical device performance, ensuring compliance with FDA 21 CFR 820, ISO 13485, and MDR regulations. The ideal candidate will bring strong ability to analyze failure trends, perform risk assessments, and manage regulatory reporting to ensure post-market safety. Key duties involve root cause investigation, interacting with customers, and collaborating with engineering/quality teams.   

This is an onsite role in Marlborough, MA.

What You'll Do

Process complaints and regulatory (MDR, Vigilance, other) reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner.

Responsible for evaluating and processing complaints received by a client.

Support complaint receiving and handling (documentation, coordination, investigation, resolution, and closeout)

Check accuracy of complaint files at various points in the process

 Support with follow-up activities (e.g. additional information and product)

Support complaint closure within Complaint Management System (CMS)

Assess complaint events/files for reportability per client’s process and applicable regulations

Initiate Medical Device Reports (MDR) for FDA submissions

Complete MDR/vigilance reports per client process and regulations

Regularly report to various levels of ECI/client management on the progress of Complaints and MDR.

Interface directly with client’s internal and external customers and regulatory agencies as required.

Additional items as discussed between client and ECI as determined reasonable will not require scope re-evaluation.

What We Look For

Bachelor’s degree in engineering, biomedical engineering, or scientific field, or equivalent industry experience.

5-6 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device industry. 

Strong knowledge of FDA 21 CFR Part 820, 21 CFR Part 803 (MDR), and ISO 13485.

Experience with QMS software and databases, plus the ability to read technical documents. 

Professional verbal and written communication skills to interact with clinicians and users. 

Excellent documentation skills for creating detailed investigation reports. 

Strong ability to analyze complex data to identify patterns. 

Please email your resume to mike.king@eci-rx.com  and mention req #7815 MASS MEDIC or apply online today!

Careers | ECI | Enhanced Compliance Inc.

ECI is an equal opportunity employer. 

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. 

At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future.  At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.