Job Description

As a Global MDR Submission Analyst II OSTA team member, you will be responsible for timely regulatory reporting assessments and reassessments of global complaints, preparation and submission of initial/importer/supplemental MDR reports for post market activities per 21CFR803. Performs follow-up to obtain additional information for Adverse Events by collaborating with Field Specialists, Sales Representatives, Engineers, Technicians, Clinicians, and Customers directly. Performs routine assignments with minimal direction from manager; requires general instruction for new or special assignments from Manager. The Analyst II will maintain quality documents to ensure compliance with global medical device guidance documents. The Analyst II requires working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803.

Job Duties

• Review incoming complaints to determine the facts of the case.
• Verify information including information available in ancillary systems data sources. (For example: Datasweep, SAP)
• Performs follow-up to obtain additional information for Adverse Events by collaborating with Field Specialists, Sales Representatives, Engineers, Technicians, Clinicians, and Customers directly.
• Conducts timely initial MDR reportable assessment/ submission per 21CFR803.
• Conducts timely re-assessments when new information has been received to determine if an initial or supplemental MDR is required per 21CFR803.
• Assist with preparation and submission of FDA Additional Information responses, and associated documentation to the FDA and Manufacturing Business Centers (MBCs).
• Assist Global MDR Submission Management in the successful identification and resolution of quality issues associated with complaints.
• Key Team player working closely with other Global MDR Submission Associates
• Perform other duties as assigned

Job Qualifications

Required:

• Bachelor of Science degree with 1-3 years medical device experience or Associate degree with scientific discipline,or License Practical Nurse (LPN) with 3-5 years medical device experience (i.e. LPN, Associate RN, X-Ray technician, Biomedical technician) Complaint Handling/ Customer Service experience in the Medical Device/ Pharmaceutical required.
• Must be able to maintain good attendance regular scheduled hours.
• Must be able to follow standard practices and procedures.
• Attention to detail and accuracy required.
• Strong analytical and organizational skills required.
• Must be able to prioritize workload in order to meet regulatory/ procedural deadlines.
• Basic knowledge of medical terminology and human anatomy.
• Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, 21CFR820, and 21CFR803.
• Applies professional concepts and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems.
• Follows standard practices and procedures in analyzing situations or data from which answers can be obtained.

Preferred:

• Effective communication skills - both written and verbal English language.
• Ability to effectively prioritize and manage workload.
• Knowledge/ ability to utilize various software/database sources.
• The ability to read, write and communicate effectively in English is required; includes clear, understandable speech and demonstrated comprehension skills.
• The ability to collaborate and be a team player.
• Must be able to demonstrate a working proficiency in operating a personal computer and to perform basic word processing/spreadsheet tasks using Microsoft Excel and Word applications.

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