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Sr Post Market Surveillance Specialist
Category: Health Care Industry
  • Your pay will be discussed at your interview
  • Requisition #:
    Post Date:
    **Must Have: Minimum Requirements**
    oKnowledge of:
    -AIMD Directive: 90/385/EEC
    -IVD Directive: 98/97/EC

Job code: lhw-e0-89751020

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  Job posted:   Thu May 17, 2018
  Distance to work:   ? miles
  1 Views, 0 Applications  
Sr Post Market Surveillance Specialist

Sr Post Market Surveillance Specialist
Jacksonville, Florida, United States
10 hours ago
**Careers that Change Lives**
Your dedication is important to our customers and, most importantly, to their patients.
Medtronic is currently seeking a Sr. Post Market Surveillance Specialist.
Do meaningful work, make a difference, and improve lives -- starting with your own.
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
**A Day in the Life**
+ Ownership of the Post market Surveillance Process at ENT
+ Creation and updating of product PMS plans
+ Creation and updating of product PMS reports
+ Backup for Product Hold / Field Corrective Action activities
+ Work with Clinical on Clinical Evaluation Reports (CERs)
Responsibilities may include the following and other duties may be assigned.
+ Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
+ Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
+ Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
+ Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
+ Co-ordinates legal requests in support of government investigations or litigations.
+ Ensures the quality assurance programs and policies are maintained and modified regularly.
+ Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
Bachelor's degree
4+ years of Quality related experience or 2+ years of Quality related experience with a Master's degree
**Nice to Have**
oStrong attention to detail
oKnowledge ofbasic anatomy, physiology and medical terminology
-21CFR, Section 820, Quality System Regulation
-21CFR Section 803, Medical Device Reporting
-ISO 13485, Quality Systems, Quality Management Systems
-45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations
-MDD Directive (Council Directive 93/42/EEC for Medical Devices)
-PC 1998-783 - Canadian Medical Device Regulation (CMDR)
oStrong analytical skills (problem solving, critical thinking)
oExcellent communication skills (oral and written), with strong organizational and analytical skills
oAbility to work independently or in a team setting
**About Medtronic**
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life section of this

job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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