Postmarket Surveillance Analyst
Job Description Job Description This is a 1
year role in Plano, TX Pay Range:
$33-42/hr Description:
Initiates and manages the complaint file (present complaint, follow up, collect data, enter into system, then file report to FDA / other agencies) Maintains accurate entry of complaints in the database Communicates to field representatives regarding information needed specific to product complaints (e.
G.
physicians, hospital personnel, sales representatives, international offices) Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.
g.
FDA, ECA) and submits reports within required time frame Diligent of any unusual trends in product complaints and communicates them with mgmt.
Complies with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors.
Manages and maintains high level complaints, regulatory reports, (FDA) investigation procedures,
Qualifications:
B.
S is required; Biomedical Engineering; Life Science or closely related discipline or relevant combination; OR Associate with 3 years of undergraduate experience Will consider Fresh Graduates Comfortable in a high volume work environment Healthcare/clinical background a plus 1 year of Customer Service, compliant reporting, Class 3 experience Will consider Quality background Customer Service skills Time Management Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Proficient with Microsoft office suite (Excel), SAP, typing, self-sufficient Company Description Synectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States.
We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling.
We also seek to justify our clients expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day.
Our success has depended on our consistent ability to achieve both of these goals.
Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions.
The technologies we support have always been responsive to this extremely broad spectrum.
In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds.
This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.
Synectics is an Equal Opportunity Employer.
Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Premiums are subsidized by Synectics.
Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance:
Synectics offers eligible employees vision insurance through VSP.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.
In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.
Only one Certification Bonus per calendar year may be awarded per employee.
Only current, active employees will be eligible to receive this bonus.
It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Company Description Synectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States.
We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling.
We also seek to justify our clients expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day.
Our success has depended on our consistent ability to achieve both of these goals.
rnrnSynectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions.
The technologies we support have always been responsive to this extremely broad spectrum.
In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds.
This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.
rnSynectics is an Equal Opportunity Employer.
rnrnHealthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Premiums are subsidized by Synectics.
rnrnDental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
rnrnVision Insurance:
Synectics offers eligible employees vision insurance through VSP.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
rnrnTechnical Certification Bonus:
rnSynectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.
In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.
Only one Certification Bonus per calendar year may be awarded per employee.
Only current, active employees will be eligible to receive this bonus.
It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
by Jobble Recommended Skills Biology Clinical Works Communication Customer Service Databases Hardworking And Dedicated Estimated Salary: $20 to $28 per hour based on qualifications.
year role in Plano, TX Pay Range:
$33-42/hr Description:
Initiates and manages the complaint file (present complaint, follow up, collect data, enter into system, then file report to FDA / other agencies) Maintains accurate entry of complaints in the database Communicates to field representatives regarding information needed specific to product complaints (e.
G.
physicians, hospital personnel, sales representatives, international offices) Independently assesses the complaint to determine if a medical device report needs to be filed with various global regulatory agencies (e.
g.
FDA, ECA) and submits reports within required time frame Diligent of any unusual trends in product complaints and communicates them with mgmt.
Complies with US FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors.
Manages and maintains high level complaints, regulatory reports, (FDA) investigation procedures,
Qualifications:
B.
S is required; Biomedical Engineering; Life Science or closely related discipline or relevant combination; OR Associate with 3 years of undergraduate experience Will consider Fresh Graduates Comfortable in a high volume work environment Healthcare/clinical background a plus 1 year of Customer Service, compliant reporting, Class 3 experience Will consider Quality background Customer Service skills Time Management Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization Proficient with Microsoft office suite (Excel), SAP, typing, self-sufficient Company Description Synectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States.
We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling.
We also seek to justify our clients expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day.
Our success has depended on our consistent ability to achieve both of these goals.
Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions.
The technologies we support have always been responsive to this extremely broad spectrum.
In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds.
This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.
Synectics is an Equal Opportunity Employer.
Healthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Premiums are subsidized by Synectics.
Dental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance:
Synectics offers eligible employees vision insurance through VSP.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Technical Certification Bonus:
Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.
In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.
Only one Certification Bonus per calendar year may be awarded per employee.
Only current, active employees will be eligible to receive this bonus.
It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Company Description Synectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States.
We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling.
We also seek to justify our clients expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day.
Our success has depended on our consistent ability to achieve both of these goals.
rnrnSynectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions.
The technologies we support have always been responsive to this extremely broad spectrum.
In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds.
This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.
rnSynectics is an Equal Opportunity Employer.
rnrnHealthcare Insurance:
Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Premiums are subsidized by Synectics.
rnrnDental Insurance:
Synectics offers eligible employees and their dependents a dental plan through MetLife.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
rnrnVision Insurance:
Synectics offers eligible employees vision insurance through VSP.
Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
rnrnTechnical Certification Bonus:
rnSynectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.
In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.
Only one Certification Bonus per calendar year may be awarded per employee.
Only current, active employees will be eligible to receive this bonus.
It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
by Jobble Recommended Skills Biology Clinical Works Communication Customer Service Databases Hardworking And Dedicated Estimated Salary: $20 to $28 per hour based on qualifications.
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