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Medical Device Reporting Team Leader
Eingestellt von Edelway
Gesuchte Skills: Support, Consultants
Projektbeschreibung
Medical Device Reporting Team Leader
Our global multinational pharmaceutical client based in the Bern/Basel area is currently looking for a MDR Team Leader/Post Market Risk Manager to join them on a long term basis.
THE ROLE
*Ensure appropriate medical surveillance and post-market review for our client's products.
*Assess and resolve product issues that have potential clinical implications for patient population including MDR (Medical Device Reporting) event reporting decisions.
*Be the medical professional for our client's USA Medical Device/Vigilance Reporting system.
*Be responsible for coordination of Health Hazard Analysis, consultation with medical consultants as necessary, as well as involvement in post market actions such as product recall.
*Provide guidance and direction in the determination and assessment of clinically significant post market issues
*Coordinate and conduct MDR decision meetings
*Provide direction/medical opinion on all MDR decisions
*Work cooperatively with Product Development groups to foster understanding of regulatory requirements regarding post market issues
*Responsible for determining, developing and/or coordinating health hazard analyses and risk assessments
*Engage in cooperative efforts for coordination and implementation of product recalls
*Maintain post market clinical regulatory database, including Risk Assessments and Health Hazard Evaluations
*Review clinical and trade publications for relevant news
*Provide general medical knowledge for regulatory submissions group as deemed necessary to ensure adequacy of support for all claims, pertaining to safety, efficacy and performance.
*Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
*Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
YOUR PROFILE
*Registered Nurse or Nurse Practitioner
*5 years minimum medical experience in nursing
*Knowledge of internal and external bone fixation devices and implants
*Experience or general medical knowledge of Orthopedic, Spine, and Craniofacial/Maxillofacial implants and instruments
*General knowledge of the FDA requirements for medical devices and MDR reporting
*Orthopedic Surgery is a plus
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.
Our global multinational pharmaceutical client based in the Bern/Basel area is currently looking for a MDR Team Leader/Post Market Risk Manager to join them on a long term basis.
THE ROLE
*Ensure appropriate medical surveillance and post-market review for our client's products.
*Assess and resolve product issues that have potential clinical implications for patient population including MDR (Medical Device Reporting) event reporting decisions.
*Be the medical professional for our client's USA Medical Device/Vigilance Reporting system.
*Be responsible for coordination of Health Hazard Analysis, consultation with medical consultants as necessary, as well as involvement in post market actions such as product recall.
*Provide guidance and direction in the determination and assessment of clinically significant post market issues
*Coordinate and conduct MDR decision meetings
*Provide direction/medical opinion on all MDR decisions
*Work cooperatively with Product Development groups to foster understanding of regulatory requirements regarding post market issues
*Responsible for determining, developing and/or coordinating health hazard analyses and risk assessments
*Engage in cooperative efforts for coordination and implementation of product recalls
*Maintain post market clinical regulatory database, including Risk Assessments and Health Hazard Evaluations
*Review clinical and trade publications for relevant news
*Provide general medical knowledge for regulatory submissions group as deemed necessary to ensure adequacy of support for all claims, pertaining to safety, efficacy and performance.
*Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
*Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
YOUR PROFILE
*Registered Nurse or Nurse Practitioner
*5 years minimum medical experience in nursing
*Knowledge of internal and external bone fixation devices and implants
*Experience or general medical knowledge of Orthopedic, Spine, and Craniofacial/Maxillofacial implants and instruments
*General knowledge of the FDA requirements for medical devices and MDR reporting
*Orthopedic Surgery is a plus
If it sounds like your next challenge, send us your CV and we will contact you shortly to discuss it further.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Organisation/Management, Sonstiges