Post Market Risk Manager

Solothurn  ‐ Vor Ort
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Schlagworte

Beschreibung

Post Market Risk Manager
CHF Negotiable
Solothurn, Switzerland
6 month contract

Our client is seeking an experienced Post Market Risk manager with medical/pharmaceutical experience to join their team onsite in Switzerland, Solothurn.

Responsibilities:
Ensure appropriate medical surveillance and post-market review for all our clients products. This
Complaint/MDR Team leader will assess and resolve product issues that have potential clinical
implications for patient population including MDR event reporting decisions. The Post Market Risk
Manager is the medical professional for our client's Medical Device/Vigilance Reporting system.
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.

POSITION DUTIES & RESPONSIBILITIES:
* 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.
* Other duties as assigned.

PROFESSIONAL EXPERIENCE REQUIREMENTS:
* 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.

EDUCATIONAL REQUIREMENTS:
Higher education in Engineering, Biology, Medicine, or related fields.

General Product Knowledge on Medical Devices or related fields.

Start
keine Angabe
Dauer
6 months
Von
Berry Technical
Eingestellt
24.05.2013
Projekt-ID:
541587
Vertragsart
Freiberuflich
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