Arthrex
Overview
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical MDR Specialist for our Santa Barbara, CA facility. The Clinical MDR Specialist performs reportability decision trees for ACT product complaints; manages complaint investigations including those involving potential or existing adverse events associated with the use of ACT medical device products. Assists with researching and compiling regulatory reports for the United States and International regulatory agencies in accordance with applicable regulations; support the Quality Department to maintain and improve the Arthrex Global Quality Management System (QMS) in compliance with FDA QSR, ISO 13485, MDSAP, and all other applicable regulatory requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.
Essential Duties and Responsibilities
Assist with regulatory compliance and medical device reporting for ACT product complaints.
Execute reportability decision trees to determine reportability requirements.
Review complaint investigation results for completeness and accuracy.
Record complaint investigation finds in the complaint management system.
Manage physical inventory of complaint devices associated with a reportable event.
Organize and coordinate Quality projects to ensure Arthrex QMS compliance.
Support business/process owners in developing, revising and reviewing QMS documents.
Guide and train QMS software users on regulatory and compliance requirements.
Assist with Internal and External Audits, including preparation, documentation requests, and support.
Education and Experience
Bachelor’s degree in health sciences, biomedical engineering, or nursing is required
Experience working in the medical device or drug/pharma industry with adverse event reporting responsibility preferred
Skills and Knowledge
Experience with business or technical writing preferred
Excellent interpersonal and communication skills preferred
Experience working with personnel of various skills sets and education levels
Good organizational and time management skills
Ability to interface with internal departments such as Repair, Technical Support and Product Management and with external customers such as vendors, distributors, sales reps, and medical professionals
Ability to remain detail-oriented in a fast-paced environment
Ability to work in a team setting to assure functional commitments are met
Knowledge and Skill Requirements / Specialized Courses and/or Training Knowledge of products and skills to maintain a positive approach to negative issues. High-level computer data entry skills.
Machine, Tools, and/or Equipment Skills
Microsoft Office, Microsoft Excel, PCs and office equipment.
Reasoning Ability Ability to define problems, collect data, establish facts, and draw valid conclusions.
Mathematical Skills Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills Excellent written and verbal skills and the ability to record information accurately are required for this job. Communication skills are the key to being effective in this job.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands and fingers to handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Vision Requirements Visual acuity necessary to do the job safely and effectively.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate
Arthrex Benefits
Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Lunch
Gym Reimbursement Program
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Paid Sick Leave
Volunteer PTO
Employee Assistance Provider (EAP)
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
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Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical MDR Specialist for our Santa Barbara, CA facility. The Clinical MDR Specialist performs reportability decision trees for ACT product complaints; manages complaint investigations including those involving potential or existing adverse events associated with the use of ACT medical device products. Assists with researching and compiling regulatory reports for the United States and International regulatory agencies in accordance with applicable regulations; support the Quality Department to maintain and improve the Arthrex Global Quality Management System (QMS) in compliance with FDA QSR, ISO 13485, MDSAP, and all other applicable regulatory requirements. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.
Essential Duties and Responsibilities
Assist with regulatory compliance and medical device reporting for ACT product complaints.
Execute reportability decision trees to determine reportability requirements.
Review complaint investigation results for completeness and accuracy.
Record complaint investigation finds in the complaint management system.
Manage physical inventory of complaint devices associated with a reportable event.
Organize and coordinate Quality projects to ensure Arthrex QMS compliance.
Support business/process owners in developing, revising and reviewing QMS documents.
Guide and train QMS software users on regulatory and compliance requirements.
Assist with Internal and External Audits, including preparation, documentation requests, and support.
Education and Experience
Bachelor’s degree in health sciences, biomedical engineering, or nursing is required
Experience working in the medical device or drug/pharma industry with adverse event reporting responsibility preferred
Skills and Knowledge
Experience with business or technical writing preferred
Excellent interpersonal and communication skills preferred
Experience working with personnel of various skills sets and education levels
Good organizational and time management skills
Ability to interface with internal departments such as Repair, Technical Support and Product Management and with external customers such as vendors, distributors, sales reps, and medical professionals
Ability to remain detail-oriented in a fast-paced environment
Ability to work in a team setting to assure functional commitments are met
Knowledge and Skill Requirements / Specialized Courses and/or Training Knowledge of products and skills to maintain a positive approach to negative issues. High-level computer data entry skills.
Machine, Tools, and/or Equipment Skills
Microsoft Office, Microsoft Excel, PCs and office equipment.
Reasoning Ability Ability to define problems, collect data, establish facts, and draw valid conclusions.
Mathematical Skills Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills Excellent written and verbal skills and the ability to record information accurately are required for this job. Communication skills are the key to being effective in this job.
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands and fingers to handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.
Vision Requirements Visual acuity necessary to do the job safely and effectively.
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate
Arthrex Benefits
Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Lunch
Gym Reimbursement Program
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Paid Sick Leave
Volunteer PTO
Employee Assistance Provider (EAP)
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
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