The post-market Regulatory Affairs Engineer works within a team of Regulatory Affairs professionals to ensure compliance with country specific regulatory requirements for post market surveillance including complaints handling, adverse event reporting, as well as field actions.
This role will have significant visibility and a chance to make a real difference to our employees and our customers as we add value through post market insights. You will implement standard mechanisms for timely handling, assessment and disposition of customer complaints, potential reportable events and field actions, and ensure timely report submission to regulatory agencies, such as MDR. In addition, you will participate in CAPA activities to drive continuous improvement.
ESSENTIAL JOB FUNCTIONS*
Create, review, and approve incident reporting decision trees.
Create and ensure timely submission of adverse event reporting to applicable regulatory agencies such as the FDA, Health Canada, MHLW, TGA, Competent Authorities, and authorized Representatives.
Ensuring product complaints are investigated per procedures.
Function as SME (subject matter expert) for complaints handling, regulatory reporting and CAPA’s during internal and external audits.
Continuously reviewing complaints status and updating file with progress and information findings to ensure all required information is submitted to the appropriate regulatory agency in a timely manner.
Keep up to date on each countries’ health authority requirements and ensure reporting requirements and deadlines are met.
Maintain adverse event reporting log to ensure all reportable events are captured and reported per regulation.
Maintain adverse event files electronically to support compliance with regulatory requirements.
Compile, analyze and report production and post-production information as part of the Post-Market Surveillance system.
Perform data trending and statistical analysis.
Responsible for implementation of best practices to optimize quality, efficiency & productivity.
Assist in reviewing & drafting proposals to implement changes to the Quality System procedures/forms as needed to maintain compliance, improve effectiveness, & efficiency. (participate in process improvements throughout scope of role).
Assist with monitoring and remaining current with internal company procedures/policies, international QS standards and federal regulations.
OTHER DUTIES AND RESPONSIBILITIES
Supports regulatory inspections as required.
Supports the development of internal RA systems and procedures.
Support Complaint handling, field action, and CAPA activities.
Performs other duties as assigned.
Bachelor’s engineering or science degree plus 5+ years of related experience in the medical device.
Strong analytical, conceptual and critical thinking skills. A problem solving and pragmatic attitude.
Direct involvement in adverse event reporting activities is required.
Must have knowledge of regulations relative to complaint handling and reporting, such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 820)), CMDR, JPAL, TG(MD)R, and EU MDR.
Must possess strong customer focus with doing it right the first-time approach and be able to demonstrate high performance behavior of shared accountability.
Excellent verbal and written communication skills; strong attention to detail.
Willing to work at Natick MA site.
Ability to speak Mandarin Chinese is a plus.
InfuTronix is an innovative medical device company delivering industry leading technology for infusion therapy. By combining data collection with portable, intuitive, easy-to-use infusion devices, InfuTronix is committed to helping healthcare providers raise the bar on improved patient outcomes. Headquartered in Natick, MA, InfuTronix specializes in acute regional pain, EMS, PCEA, and PCA home infusion markets.