• Clinical Product Risk Manager Jobs in United States Of America - 25366852

  • United States Of America, Usa
  • Save Job
  • 7 - 10 Years
  • Posted : above 1 month

Job Description:

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level With determination, imagination and a deep caring for human life, were solving some of the most important healthcare industry challenges Together, were one global team committed to making a difference in peoples lives around the world This is a place where you can find a career with meaningful purposeimproving lives through your lifes work

About this role

The Clinical Product Risk Manager has a comprehensive skill set and thorough understanding of multiple therapeutic areas as they relate to medical devices They provide innovative solutions and lead resolution of cross-functional issues and process improvement efforts They are an SME for CERs and Clinical Risk and represent their function to internal and external cross-functional partners, while also training and managing a team of Product Risk Specialists

Your responsibilities will include

Execute, lead and train others on all aspects of Clinical Evidence and Risk Management research, analysis, interpretation and document generation Identify issues, develop and communicate proposed solutions to teams and senior management as required
Maintains clinical risk timelines required by global Regulatory Bodies
Coordinate and lead efforts to develop and maintain reports and data sets (including Clinical Evaluation Report and Risk Management Documentation deliverables), to support adherence to international regulations and reporting cadence
Develop expertise and train others in evolving requirements of international regulations, including requirements laid out in MEDDEV and EU MDR
Leads the development of clinical risk strategy by conducting meetings with the appropriate departments and individuals to obtain feedback/input Provides project leadership and scientific expertise throughout product development and implementation of local or global Regulatory requirements
Independently utilize understanding of Urology to identify and interpret information impacting risk management Lead junior staff through process and their authorship of clinical evaluations in support of various regulations globally
Identifies functional area specific project risks Develops and executes contingency and mitigation plans for programs Work with contractors and/or vendors to complete work as necessary and ensure compliance to training, corporate standards and regulatory agencies
Serves as Risk Management SME on project team; makes decisions and clearly communicates pertinent project/function information Determines clinical and cross-functional resources and expense requirements for team Collaborates with functional manager on quarterly budget issues
Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan Negotiate resource utilization to ensure deliverables are met within timeline and budget
Identify, propose and lead process improvements within function Develop best practice guidelines to support company or US/OUS regulatory standards, and contribute to development of functional SOPs and WIs Influence company standards development by participating as a Clinical SME for Quality initiatives
Serves as SME and Function representative in internal and external audits including audit participation, back room SME, preparing audit responses and supporting process improvements resulting from the audit
Provides/facilitates responses to Regulatory Bodies regarding Clinical queries

What were looking for in you

Minimum Qualifications

Bachelors degree in healthcare/life science related field
7 years of related work experience in clinical trials, clinical research, and/or clinical quality
3 years of clinical/scientific writing
Proven ability to meet timelines dependent upon cross functional team collaboration
Management experience required

Preferred Qualifications

Advanced degree (Masters degree and above) or Medical/Nursing Degree preferred Healthcare related background preferred
Urology products/studies experience
Able to work independently to solve complex issues
Broad exposure to Product Development teams (eg DQA, Regulatory, R&D)
Communication skills and customer focus; ability to work closely with global cross-functional partners
Solid understanding of adverse event reporting requirements globally
Experience interacting with Regulatory Authorities or Notified Bodies

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Others - other Industry
Functional Area : Bio Tech/R&D/Scientist
Role : Clinical Research
Salary : As per Industry Standards
Deadline : 09th Jun 2020

Key Skills:

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