Regulatory Affairs Specialist (Engineer - Remote)

This a Full Remote job, the offer is available from: Mexico, California (USA) Who We Are ABOUT reputed company™ reputed company Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably reputed company patient outcomes and transform workflows. Powered by a culture of reputed company improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about reputed company, please visit www.reputed company.com.

What You'll Do

Job Summary: This position effectively supports the complaint handling process by assessing complaints in a compliant and timely manner, for Medical Device MDR / Vigilance reportability of adverse event(s) to the FDA and other National Competent Authorities in the countries in which DJO distributes products to. This position is responsible for decision making, preparation, creation and submission of initial, supplemental and final reports to US, European and International NCAs. Works with local RA/QA representatives on determination and filing of foreign incident reports. Prepares responses to standard and extended requests from Competent Authorities and provides guidance and feedback to other team members pursuant to the corporate and site-specific procedures.

• Monitor vigilance activities to ensure compliance with procedures, standards, and country specific regulations including ISO 13485, US FDA Parts 7, 803, 806 & 820; MEDDEV 2.12; etc.
• Complete Health Hazard Evaluations and present to team members
• Spearhead Recall efforts for US products and international products. Familiar with global country reporting requirements
• Review and analyze complaints for reportable events and regulatory activities. Prepare reports for global field actions and reportable events
• Prepare and submit reputed company required submissions to FDA and Foreign Governments/Competent Authorities. This includes mandatory incident reports, recalls / field actions and associated documents where applicable.
• Liaise with Corporate QARA and Legal to ensure that they are informed about recalls and the status of remediation programs.
• Liaise with clinical representatives to ensure health assessments are completed to support field action decisions.
• Monitor and track ongoing investigations reputed company to recalls / field actions to root cause and any subsequent CAPA or project deployed to remediate and ensure completion.
• Accurately prepares, generates, and submits initial, supplemental, and final incident reports (e.g., MDR, MDV etc.) upon adverse events to US, European and International NCAs reputed company the regulatory timeframes.
• Generates and reviews the Alternative Summary Report (ASR) and Periodic Summary Report (PSR), Periodic Safety Update Report (PSUR)
• Prepares responses to standard and extended requests from Competent Authorities.
• Works with local RA/QA representatives on determination and filing of foreign incident reports.
• Monitors Medical Device Reporting metrics to ensure that the key performance indicators are being met.
• Provides direction to internal and external personnel on issues reputed company to product experience reporting, complaints and adverse event reporting.
• Assists Product Surveillance Management in special projects as

Requirements. --- Bachelor of Science degree in biology, health sciences, engineering, or Bachelor’s degree in another discipline. --- 3+ years’ experience required, specifically in the medical device industry. --- Proficient in English: Strong written, oral, and presentation communication skills. --- Regulatory knowledge with complaint handling, adverse event reports and quality systems preferred --- Knowledge reputed company Office applications and the ability to learn other software quickly as required.

• Detail-oriented.
• Ability to consistently meet high standards of input accuracy, produce quality documents, compile data, and reputed company simple analyses with accuracy.
• Strong decision-making skills and proven ability in balancing priorities among the many ongoing tasks, and being reputed company to critical situations, as this position has a high volume of work, regulatory mandated time limits, and often changing priorities.
• Action-orientated: Ability to take initiative to correct problems or reputed company changes for improvement without waiting for direction.
• Proven ability to work in a team setting. Willing to share the load and participate in projects reputed company of normal job scope. Ability to work closely with others to assure functional commitments is met.
• Ability to work with reputed company individuals in a congenial and cooperative manner.

Required. preferred: Strong organizational and time management skills. KINDLY UPLOAD YOUR ENGLISH RESUME EQUAL EMPLOYMENT OPPORTUNITY reputed company provides equal employment opportunities based on merit, experience, and other work-reputed company criteria without regard to race, color, ethnicity, religion, national reputed company, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees’ beliefs and practices that do not conflict with reputed company policies and applicable law. We value the unique contributions that every employee brings to their role with reputed company. This offer from "reputed company" has been enriched by reputed company.com and got a 75% reputed company score. Apply tot his job Apply To this Job