Associate MDR/Vigilance Specialist

Responsible for facilitating complaint handling, regulatory reporting, and post-market surveillance activities in compliance with FDA and international regulations.

Requirements

• Bachelor’s degree in Biomedical Engineering, Nursing, or related field (required)

• Strong MDR documentation or technical writing experience

• Proficient computer skills including Microsoft Office (Outlook, Word, Excel)

• Ability to read and type English proficiently

• Experience working with databases or OneNote preferred

• Background in biomedical engineering, mechanical engineering, nursing, or related healthcare field

Preferred Skills

• Complaint handling or customer service experience

• Knowledge of clinical settings and product applications

• Experience with regulatory submissions and reportability assessments

Responsibilities

• Facilitate complaint communications and assess reportability for regulatory compliance and patient safety impact

• Complete and submit regulatory reports within mandated FDA timeframes

• Receive, evaluate, and investigate product complaints, gathering data from clinical staff, field representatives, and internal teams

• Document product events and request additional information to ensure full understanding of complaints

• Develop and maintain internal systems, methods, and procedures to support post-market surveillance

• Participate in cross-functional teams to evaluate and implement system changes and upgrades

Pay: 25-29

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client.

Pay Details: $25.00 to $29.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.