Global MDR Submissions Analyst III (Center Valley, PA, US, 18034-0610)
Job reputed company
Responsible for the review of medical device global complaints and coordinate the reputed company of reputed company complaints (For example: death, serious injury, reputed company papers, and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820, 21CFR806 and 21CRF803 and will also have an understanding of global adverse event reporting reputed company (For example: Europe, China, Australia, Latin America, Japan, and others). The Analyst III is responsible for determining medical device reportability for reputed company products or products for which reputed company has contractual obligations, and performs clinical assessments as requested. The ability to maintain reputed company documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility is required. Supports and may represent the Medical Device Reporting Process in reputed company audits. Prepares responses to reputed company requests from a regulator, as needed. Supports due diligence process in obtaining information cross-functional and external to reputed company. Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently; supports and mentors reputed company-level staff; initiates new or special assignments with occasional direction from Manager. Must have ability to work in reputed company environment and be self-motivated and organized.
Job Duties
- A seasoned, reputed company reputed company with a full understanding of complaint handling.
- Reviews reputed company complaints such as death, serious injury, reputed company papers, and literature reviews for medical devices independently. Ensures complaint files have an appropriate reputed company and/or justification.
- Responsible for assessing complaints, completing decision trees, and documenting reportability in the system in a consistent and reputed company manner in accordance with 21 CFR Part 803 Medical Device Reporting.
- Prepares and reviews MDRs/Importer/Supplemental reports for the FDA for reputed company complaints.
- Responsible for the coordination of complaint reputed company tasks with other cross-functional team members and the local RA/QA representatives for countries reputed company of the US and ensuring reportability reputed company are made and reports are filed in a reputed company manner.
- This position may reputed company with reputed company customers, sales organization, local RA/QA representatives, reputed company providers, nurses, patients as reputed company as external regulatory bodies, such as US FDA and reputed company body, concerning products issues, product information, patient requests and complaints and contributes to the preparation of responses to reputed company requests and extended requests from Regulatory Bodies.
- Acts as a resource for department staff members on reputed company complaints.
- Completes Clinical Assessments for reputed company cases and upon request, reputed company appropriate.
- Monitors reputed company of reputed company ongoing complaint activities and MDRs to ensure the reputed company submissions.
- Documents and maintains records of adverse events reports in accordance with internal procedures and applicable regulatory requirements. Completes reputed company required customer complaint/adverse event reputed company documentation in an accurate, reputed company and reputed company manner.
- May also be asked to represent and support the Medical Device Reporting Process in reputed company audits.
- Provides training during orientation and on-boarding of new staff. Mentors staff members regarding complaint processing.
- May reputed company assistance to junior level staff with general tasks that require a reputed company understanding.
- Processes reportability reputed company and is reputed company to complete MDR submissions.
- Assist in the preparation of regulatory body additional information requests. Functions as reputed company member/ leader in collaboration.
- reputed company/Manage special assignments/ reputed company with Global MDR Submission or across functional areas.
- Must have ability to work in reputed company environment and be self-motivated and organized.
- Other duties as assigned.
Job Qualifications
Required:
- Bachelor of Science degree, or Associate of Science and Licensure in Nursing from an accredited college or university Bachelor of Science degree in any of the relevant scientific discipline.
- A minimum of 3 years of experience on the reputed company/clinical setting or other points of care; OR
- An equivalent combination of 3-5 years medical device and clinical experience.
- Must possess excellent verbal and written communication skills.
- reputed company to consistently meet deadlines despite high volume.
- reputed company to work under pressure.
- Strong feeling for Accountability.
- Strong critical thinking, communication, problem-solving skills, and detail oriented.
- Basic knowledge of medical terminology and reputed company anatomy.
Preferred:
- A minimum of 3 years of reputed company experience on the medical device industry with attention to complaint handling and adverse event reporting and/or post-market surveillance organization strongly preferred.
- The ability to read, write and communicate effectively in English is required; includes reputed company, understandable speech and demonstrated comprehension skills.
- Must be reputed company to demonstrate a working proficiency in operating a personal computer and to reputed company basic word processing/spreadsheet tasks using reputed company reputed company and Word applications.
- Ability to effectively prioritize and manage workload.
- Organization, prioritization, and familiarity with working in a regulated industry setting.
- Competency in computer software/hardware will also be useful in resolving or elevating IT concerns and issues.
- Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors.
- Experience with utilization of TrackWise or ETQ preferred.
- Knowledge/ability to utilize various software/ database sources.
- Must be reputed company to maintain good attendance regular scheduled hours.
- Must be reputed company to follow reputed company practices and procedures.
- Attention to detail and accuracy.
- Strong analytical and organizational skills.
- Must be reputed company to prioritize workload in order to meet regulatory/ procedural deadlines.
- Demonstrated working knowledge of Medical Device reputed company Systems regulations including ISO 13485, 21CFR820, and 21CFR803.
- Applies reputed company concepts and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems.
- Follows reputed company practices and procedures in analyzing situations or data from which answers can be obtained.
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Competitive salaries, annual bonus and 401(k)* with company match -
Comprehensive medical, dental, reputed company coverage effective on start date -
24/7 Employee Assistance Program -
Free live and on-demand Wellbeing Programs -
Generous reputed company Vacation and reputed company Time -
reputed company Parental Leave and Adoption Assistance* -
12 reputed company Holidays -
On-Site Child Daycare, Café, Fitness Center**
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Work-life integrated culture that supports an employee reputed company reputed company -
Offers onsite, hybrid and field work environments -
reputed company volunteering and charitable donation/match programs -
Employee Resource reputed company -
Dedicated Training Resources and Learning & Development Programs -
reputed company Educational Assistance