Remote Complaint Handling Specialist

12-Month Contract | Full Benefits Available We are seeking a detail-oriented Complaint Handling Specialist to support global medical device complaint investigations and regulatory reporting activities. This is a 12-month contract opportunity with benefits, supporting a growing and collaborative regulatory and quality team. Position Overview The Complaint Handling Specialist is responsible for receiving, documenting, investigating, and closing medical device complaints in accordance with global regulatory requirements. This role partners cross-functionally with Quality Assurance, Regulatory Affairs, and global affiliates to ensure timely and compliant resolution of complaint files.

Key Responsibilities

• Receive, review, and document complaints related to medical devices across global markets
• Conduct thorough investigations by gathering relevant information and performing follow-up activities
• Assess complaints for adverse event reportability under global regulations
• Prepare and submit initial and follow-up Medical Device Reports (MDRs) and equivalent international submissions (FDA, BfArM, etc.)
• Ensure investigations are complete, accurate, compliant, and closed within required timelines
• Collaborate with QA, Regulatory Affairs, and international affiliates to resolve complaints
• Monitor complaint trends and escalate significant findings to management
• Maintain compliance with EU MDR, FDA 21 CFR Part 820, ISO 13485, and company procedures

Qualifications

Education & Experience

• Required:
• Associate's or Bachelor’s degree in Life Sciences or related field
• 1+ year of medical device complaint handling experience
• Preferred:
• 2-3+ years of related complaint experience in product safety within a healthcare or clinical environment
• Healthcare background strongly preferred (LVN, RN, Medical Technologist, Medical Assistant, etc.)

Required Skills & Competencies

• Strong understanding of FDA 21 CFR Part 820 and ISO 13485
• Familiarity with EU MDR and global medical device reporting requirements
• Analytical and problem-solving skills
• Strong attention to detail
• Excellent written and verbal communication skills
• Knowledge of medical terminology
• Understanding of HIPAA and privacy regulations

Benefits (for contract employees)

• PTO
• Holiday Pay
• Medical
• Dental
• Vision
• 401(k)

If you have experience in medical device complaint investigations and regulatory reporting and are looking to join a collaborative and fast-paced environment, we encourage you to apply. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly® Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Apply tot his job Apply To this Job