Job DescriptionOne of our large pharmaceutical clients is actively hiring a Remote Complaints Specialist for their Medical Device Combination Product Team. They will be responsible for-Supporting Product Quality activities associated with complaint handling and regulatory reporting submissions of Medical Device / Drug combination products.-Responsible for analysis and assessment of reported events involving Medical Device / Drug combination products to determine FDA MDR and ROW Regulatory Bodies reportability, and to ensure compliance with FDA 21 CFR 829 and ISO 13485, while adhering to strictly enforced deadlines.-Completion of Reportability Decision Trees for US and ROW-Working with Clinicians and Safety Unit to ensure accurate and timely reportingThis is year long contract with potential extensions.We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .Skills and Requirements2-3 years experience with Medical Device / Combination Product Complaint HandlingBachelors degree in Engineering, or related fieldReportability assessment experienceVeeva or Trackwise experiencePost Market Surveillance Argus nullWe are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
