Regulatory Affairs Specialist (Engineer - Remote)
This a Full Remote job, the offer is available from: Mexico, California (USA)
Who We Are
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous 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 Enovis, please visit www.enovis.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 all 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 related 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 within 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 related 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 Microsoft 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 perform simple analyses with accuracy.
• Strong decision-making skills and proven ability in balancing priorities among the many ongoing tasks, and being responsive 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 make changes for improvement without waiting for direction.
• Proven ability to work in a team setting. Willing to share the load and participate in projects outside of normal job scope. Ability to work closely with others to assure functional commitments is met.
• Ability to work with all individuals in a congenial and cooperative manner.
Required. preferred: Strong organizational and time management skills.
KINDLY UPLOAD YOUR ENGLISH RESUME
EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, e
Apply Now
Apply Now
Who We Are
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous 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 Enovis, please visit www.enovis.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 all 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 related 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 within 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 related 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 Microsoft 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 perform simple analyses with accuracy.
• Strong decision-making skills and proven ability in balancing priorities among the many ongoing tasks, and being responsive 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 make changes for improvement without waiting for direction.
• Proven ability to work in a team setting. Willing to share the load and participate in projects outside of normal job scope. Ability to work closely with others to assure functional commitments is met.
• Ability to work with all individuals in a congenial and cooperative manner.
Required. preferred: Strong organizational and time management skills.
KINDLY UPLOAD YOUR ENGLISH RESUME
EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, e
Apply Now
Apply Now