Job Category: Compliance & Regulation
Job Number: 11425916
Women Back to Work (WBW) candidates will also be considered for this position.
Akraya is looking for a “ Regulatory Post Market Surveillance Coordinator” for one of our clients. If the job description below is a fit, please apply directly or call Moiz at 408-816-2442. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Regulatory Reporting, Medical Device Complaint Files and Quality Record Documentation
Duration: 12+ Months
Tax Term: W2 Only
Roles and Responsibilities:
- Complete RPMS new hire training and ongoing Regulatory Post Market Surveillance training as required.
- Follow and comply with company procedures and processes relating to complaint intake, assessment and reporting.
- Process, record and close perform assigned complaint handling activities in a timely manner.
- Assists and supports other employees, teams and field personnel as necessary
- Create and submit customer failure analysis letters.
- Attach reports to complaint records; send follow up questions to customers.
- Escalate complaints to Specialist/Analyst that require additional review.
- Perform other duties as assigned.
Education: Undergraduate degree in engineering, life science, OR
Experience: 1 year of experience in Regulatory Post Market Surveillance Department with experience or exposure in the following areas:
Competency / Training: The following competencies are essential for this position:
- Basic understanding with Medical Device Complaint files and quality record documentation.
- Basic understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.).
- Basic understanding of regulatory reporting requirements for Medical Devices, complaint system, and process requirements.
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
- Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
- Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines
- Excellent interpersonal skills, ability to effectively communicate and work with both internal and external customers
- Orientation for focusing on details, with emphasis on accuracy and completeness
- Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with ERP / CRM software such as SAP a plus
- Demonstrate cross-functional communication skills in person, by email and by phone.
- Demonstrate strong written and verbal communication skills.
Please apply directly with your update resume or call Moiz at: 408-816-2442
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.