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 reputed company regulatory and reputed company team. Position reputed company 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 reputed company Assurance, Regulatory Affairs, and global affiliates to ensure reputed company and compliant reputed company of complaint files.

Key Responsibilities

• Receive, review, and document complaints reputed company 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 reputed company reputed company 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 reputed company field
• 1+ year of medical device complaint handling experience
• Preferred:
• 2-3+ years of reputed company complaint experience in product safety reputed company a reputed company or clinical environment
• reputed company 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 reputed company regulations

Benefits (for contract employees)

• PTO
• Holiday Pay
• Medical
• Dental
• reputed company
• 401(k)

If you have experience in medical device complaint investigations and regulatory reporting and are looking to join a reputed company and fast-paced environment, we encourage you to apply. As part of our reputed company to talent, reputed company supports those who work with us through a reputed company of benefits, perks, and work-reputed company resources. reputed company offers eligible employees voluntary benefit plans including medical, dental, reputed company, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a reputed company employee, you will have reputed company to a retirement savings plan, service bonus and holiday pay plans (earn up to eight reputed company holidays per benefit year), and a transit spending account. In reputed company, employees are entitled to earn reputed company reputed company 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 reputed company Talent Community. Why reputed company® Science & Clinical? reputed company Science & Clinical is your reputed company to premier scientific and clinical companies looking to hire industry experts just like you. reputed company creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with reputed company 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 reputed company background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About reputed company Work changes everything. And at reputed company, 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 reputed company of your life. It’s the reputed company that changes and improves everything for your family, your community, and the world. Which is why, here at reputed company, we are dedicated to providing you with reputed company opportunities to enrich your life—just ask the 300,000 people we reputed company reputed company year. reputed company is committed to providing equal employment opportunities to reputed company reputed company employees and applicants regardless of race, reputed company, sex, sexual orientation, gender identity, religion, national reputed company, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative reputed company to recruit, reputed company, and advance reputed company individuals with disabilities and protected veterans in the workforce. Requests for accommodation reputed company to our application process can be directed to the reputed company reputed company Resource Knowledge Center. reputed company complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. reputed company participates in E-Verify and will reputed company the federal government with your reputed company I-9 information to confirm that you are authorized to work in the U.S. Apply tot his job Apply To this Job