Post Market Reporting Analyst
Kelly Services is currently seeking a Post Market Reporting Analyst for one of our top clients in Horsham, PA.
The PQV Post Market Reporting Analyst 3 will be responsible for documenting and reviewing malfunction medical device reporting MDR data fields and assisting with end-to-end high-volume complaint handling activities for Combination Products.
There will also be responsibility for ensuring accuracy and on-time reporting.
Additionally, the role will provide feedback to the impacted PQV teams as needed and ensure completeness and consistency of complaint and regulatory reporting documentation.
The position collaborates with business partners to drive process improvements/processes and identifies opportunities to improve the accuracy, efficiency and timeliness of the complaint and MDR processes.
POSITION DUTIES RESPONSIBILITIES:
Document and review malfunction MDR data fields and potentially Vigilance Reports i.e. MDV, MPR as required.
This includes providing the completed data fields to Medical Safety to support on-time filing of initial and supplemental regulatory reports.
Evaluate reportable regulatory decisions to ensure accuracy and document written justification to support reportable regulatory decisions.
Perform end to end complaint handling activities for Combination Products as requested.
Serve as a PQV point person for post market and complaint handling regulatory questions and inquiries.
Support internal and external audits and inspections.
Provides leadership and support in execution of the quality role in the MDR process for combination products.
Partners with other PQV global teams in providing guidance on the MDR process and resolving any identified issues.
Evaluates MDR data fields and prepares routine ad hoc MDR reports for Medical Safety.
Ensures all complaint and Quality MDR targets are achieved or exceeded for timely processing of complaints, regulatory reporting to regulatory bodies, notification to management and trending.
Troubleshoots and implements corrective actions to prevent future late documentation.
Performs end to end complaint handling activities for Combination Products.
This includes initial complaint assessment, complaint follow-up, complaint coding, MDR evaluations, malfunction determination, etc.
Partners with Sites External and Internal , Intake, Medical Safety, Quality External and Internal Sites, PQM Quality Engineering, etc. to ensure comprehensive, cohesive and consistent process execution and documentation.
This includes creation and maintenance of controlled documentation e.g. Standards, SOPs, etc.
Participates on PQV project teams; supports development, effective implementation, continued maintenance, and ensures compliance is achieved and standards are met.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
3-5 years of related experience including Quality Assurance and/or Quality Control in a high-volume complaint handling unit with medical device or combination product reporting responsibilities preferred.
Possess complaint handling experience i.e. 21CFR 820.198, 21CFR 211 and working knowledge/experience with regulatory reporting requirements for combination products and medical devices i.e. 21CFR 4, 803.
Additionally, international medical device regulatory reporting expertise is desired i.e. CMDR, Meddev 2.12, etc. .
EDUCATIONAL REQUIREMENTS:
Bachelor s degree or Master s degree preferred in technical, scientific, or engineering disciplines required.
Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.
Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
Why Kelly ®?
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ® ) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a Kelly Services employee, you will have access to numerous perks, including:
Vacation and sick pay
Paid holidays
401(k) plan
Group medical, vision, dental, life, and short-term disability insurance options
Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
Kelly Learning Center offers free courses and trainings
Weekly pay
About Kelly Services ®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook (https://www.facebook.com/kellyservices) , LinkedIn (http://www.linkedin.com/company/kellyservices) and Twitter (https://twitter.com/kellyservices) .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.
About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.
Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
