MDR Specialist (St. Jude Medical) Apply Online
The MDR (Medical Device Review) Specialist manages, maintains, and tracks customer complaints through the Quality Systems Database in accordance with Site procedures and regulatory agencies, specifically, 21 CFR Part 820, 198, Complaint Files, and 21CFR Part 803, Medical Device Reporting
Showing posts with label MDR. Show all posts
Showing posts with label MDR. Show all posts
Friday, May 20, 2011
Tuesday, May 10, 2011
Medical Device Review (MDR) Specialist - St. Jude Medical, Plano, TX
Apply Online
MDR SPECIALIST - PLANO, TX (ST. JUDE MEDICAL)
The MDR (Medical Device Review) Specialist manages, maintains, and tracks customer complaints through the Quality Systems Database in accordance with Site procedures and regulatory agencies, specifically, 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting
Major Ongoing Responsibilities:
• Determine classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality
• Complete FDA MDR and DDR annual baseline reporting
• Perform analysis of complaint data
• Handle complaint investigations, which may include coordinating activities with Reliability, Servicing, Customer Service, or communicating with the Sales Representative, Physician, and /or Customer
• Documents events and findings effectively and logically
• Communicates (verbal and written) in a professional and courteous manner
Education and Training:
• Bachelors degree or relevant experience with an Associates degree in a clinical/medical discipline is required
• 3+ years related experience in post market surveillance in a Medical Device or Pharmaceutical Industry
• 1+ MDR and DDR experience required
• Knowledge of the use, development, and regulatory environment of medical devices
• Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting
• Quality focused, attentive to detail and results oriented
• Ability to work independently in fast-paced environment with little supervision
• Familiar with ISO Regulations 14971, 13485
• Computer literate, Word, Excel
• Six Sigma Green Belt training a plus
• Ability to learn quickly and multi task
Apply Online
MDR SPECIALIST - PLANO, TX (ST. JUDE MEDICAL)
The MDR (Medical Device Review) Specialist manages, maintains, and tracks customer complaints through the Quality Systems Database in accordance with Site procedures and regulatory agencies, specifically, 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting
Major Ongoing Responsibilities:
• Determine classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality
• Complete FDA MDR and DDR annual baseline reporting
• Perform analysis of complaint data
• Handle complaint investigations, which may include coordinating activities with Reliability, Servicing, Customer Service, or communicating with the Sales Representative, Physician, and /or Customer
• Documents events and findings effectively and logically
• Communicates (verbal and written) in a professional and courteous manner
Education and Training:
• Bachelors degree or relevant experience with an Associates degree in a clinical/medical discipline is required
• 3+ years related experience in post market surveillance in a Medical Device or Pharmaceutical Industry
• 1+ MDR and DDR experience required
• Knowledge of the use, development, and regulatory environment of medical devices
• Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting
• Quality focused, attentive to detail and results oriented
• Ability to work independently in fast-paced environment with little supervision
• Familiar with ISO Regulations 14971, 13485
• Computer literate, Word, Excel
• Six Sigma Green Belt training a plus
• Ability to learn quickly and multi task
Apply Online
Monday, July 12, 2010
Complaint Coordinator (MDR exp) - St Jude Medical, Plano TX
Apply Online
Hot search for a Complaint Coordinator to join our team at St Jude Medical in our Neuromodulation Division in Plano, TX!
Take your experience working with the FDA and ISO regulations, and your specific MDR / "complaint handling" experience in a medical device (or regulated industry), and make a big impact as a leader on our Postmarketing team.
Follow this link, and Apply Online
Also, feel free to email me @ sjmjobs@gmail.com
Hot search for a Complaint Coordinator to join our team at St Jude Medical in our Neuromodulation Division in Plano, TX!
Take your experience working with the FDA and ISO regulations, and your specific MDR / "complaint handling" experience in a medical device (or regulated industry), and make a big impact as a leader on our Postmarketing team.
Follow this link, and Apply Online
Also, feel free to email me @ sjmjobs@gmail.com
Friday, April 30, 2010
Manager, Complaints - St. Jude Medical
Manager, Complaints - St Jude Medical, Plano TX
Apply Online
This position is the process owner for product complaint handling for St. Jude Medical Neuromodulation Division. Responsible for process and systems, developing, maintaining and tracking corporate complaint procedures and monitoring performance of the complaint handling process.
Major, On-Going Responsibilities:
• Establish clear policies and procedures for complaint handling for all locations within the Neuromodulation Division that are compliant with current regulations.
• Responsible for timely complaint closures and linkages of investigations to individual complaint records
• Ensure complaint and MDR reporting requirements are understood and met
• Support the reporting and follow-up of product recalls, if any
• Remain current on related regulations and guidelines published by FDA and international regulatory authorities
• Research various actions taken by FDA and other regulatory bodies to gain insight into current enforcement practices and the Agency’s rationale for such actions
• Provide interpretations and direction to appropriate personnel regarding the regulatory requirements relevant to the Product Complaint and Field Support organizations
• Initiate changes to practices and procedures to ensure compliance with internal and external requirements
• Design and provide training on topics related to the compliance of the product complaint SOP’s for all applicable employees
• Bring regulatory compliance questions/issues to the attention of senior management
• Participate in internal compliance inspections/audits, as well as support other units during inspections as requested
Education & Training:
• Bachelors Degree in Engineering or related discipline
• 5+ years relevant work experience, managing complaints, MDR and recalls
• 3+ years experience applying regulations including FDA QSRs, ISO13485
• 3+ years experience in medical device or pharmaceutical industry
• Ability to understand technology, products and procedures of the supported modalities. A thorough understanding of related U.S. Regulatory laws to ensure compliance.
• Demonstrated strong written and oral communication skills
• Ability to build strong relationships, team oriented
• Ability to influence positive change effectively
• Proficient with Microsoft Office Suite (e.g., database software programs)
Other Skills/Characteristics:
• Attention to Detail – establishes and reinforces consistency, carelessness is not tolerated
• Communicates Effectively – adjusts the message to the audience to get the point across
• Decisive & Good Judgment – decisions are based on data and sound reasoning
• Influencing – champion initiatives that generate organization-wide understanding and support
• Problem solving – establish resources, processes to gather information/data for problem solving or analysis
Apply Online
This position is the process owner for product complaint handling for St. Jude Medical Neuromodulation Division. Responsible for process and systems, developing, maintaining and tracking corporate complaint procedures and monitoring performance of the complaint handling process.
Major, On-Going Responsibilities:
• Establish clear policies and procedures for complaint handling for all locations within the Neuromodulation Division that are compliant with current regulations.
• Responsible for timely complaint closures and linkages of investigations to individual complaint records
• Ensure complaint and MDR reporting requirements are understood and met
• Support the reporting and follow-up of product recalls, if any
• Remain current on related regulations and guidelines published by FDA and international regulatory authorities
• Research various actions taken by FDA and other regulatory bodies to gain insight into current enforcement practices and the Agency’s rationale for such actions
• Provide interpretations and direction to appropriate personnel regarding the regulatory requirements relevant to the Product Complaint and Field Support organizations
• Initiate changes to practices and procedures to ensure compliance with internal and external requirements
• Design and provide training on topics related to the compliance of the product complaint SOP’s for all applicable employees
• Bring regulatory compliance questions/issues to the attention of senior management
• Participate in internal compliance inspections/audits, as well as support other units during inspections as requested
Education & Training:
• Bachelors Degree in Engineering or related discipline
• 5+ years relevant work experience, managing complaints, MDR and recalls
• 3+ years experience applying regulations including FDA QSRs, ISO13485
• 3+ years experience in medical device or pharmaceutical industry
• Ability to understand technology, products and procedures of the supported modalities. A thorough understanding of related U.S. Regulatory laws to ensure compliance.
• Demonstrated strong written and oral communication skills
• Ability to build strong relationships, team oriented
• Ability to influence positive change effectively
• Proficient with Microsoft Office Suite (e.g., database software programs)
Other Skills/Characteristics:
• Attention to Detail – establishes and reinforces consistency, carelessness is not tolerated
• Communicates Effectively – adjusts the message to the audience to get the point across
• Decisive & Good Judgment – decisions are based on data and sound reasoning
• Influencing – champion initiatives that generate organization-wide understanding and support
• Problem solving – establish resources, processes to gather information/data for problem solving or analysis
Medical Device Report (MDR) Specialist
MDR Specialist - St Jude Medical, Plano, TX
Apply Online
The MDR (Medical Device Report) Specialist manages, maintains, and tracks customer complaints through the Quality Systems Database in accordance with Site procedures and regulatory agencies, specifically, 21 CFR Part 820, 198, Complaint Files, and 21CFR Part 803, Medical Device Reporting.
Major Ongoing Responsibilities:
• Determine classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality
• Complete FDA MDR and DDR annual baseline reporting
• Perform analysis of complaint data
• Handle complaint investigations, which may include coordinating activities with Reliability, Servicing, Customer Service, or communicating with the Sales Representative, Physician, and /or Customer
• Documents events and findings effectively and logically
• Communicates (verbal and written) in a professional and courteous manner
Education and Training:
• Bachelors degree or relevant experience with an Associates degree in a clinical/medical discipline is required
• 3+ years related experience in post market surveillance in a Medical Device or Pharmaceutical Industry
• 1+ MDR and DDR experience required
• Knowledge of the use, development, and regulatory environment of medical devices
• Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting
• Quality focused, attentive to detail and results oriented
• Ability to work independently in fast-paced environment with little supervision
• Familiar with ISO Regulations 14971, 13485
• Computer literate, Word, Excel
• Six Sigma Green Belt training a plus
• Ability to learn quickly and multi task
Apply Online
The MDR (Medical Device Report) Specialist manages, maintains, and tracks customer complaints through the Quality Systems Database in accordance with Site procedures and regulatory agencies, specifically, 21 CFR Part 820, 198, Complaint Files, and 21CFR Part 803, Medical Device Reporting.
Major Ongoing Responsibilities:
• Determine classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality
• Complete FDA MDR and DDR annual baseline reporting
• Perform analysis of complaint data
• Handle complaint investigations, which may include coordinating activities with Reliability, Servicing, Customer Service, or communicating with the Sales Representative, Physician, and /or Customer
• Documents events and findings effectively and logically
• Communicates (verbal and written) in a professional and courteous manner
Education and Training:
• Bachelors degree or relevant experience with an Associates degree in a clinical/medical discipline is required
• 3+ years related experience in post market surveillance in a Medical Device or Pharmaceutical Industry
• 1+ MDR and DDR experience required
• Knowledge of the use, development, and regulatory environment of medical devices
• Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting
• Quality focused, attentive to detail and results oriented
• Ability to work independently in fast-paced environment with little supervision
• Familiar with ISO Regulations 14971, 13485
• Computer literate, Word, Excel
• Six Sigma Green Belt training a plus
• Ability to learn quickly and multi task
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