Associate Global Medical Safety Director (Part Time/Remote US)

Principal Responsibilities

Quality Assurance and Regulatory Affairs

• Provide subject matter expertise for discussions of patient complaints and nonconformance to the development and completion of Risk Evaluations, Health Hazard Evaluations, and Event Investigations Files
• Direct involvement representing Clinical and Medical Affairs on the Product Safety Review Board.
• Provide subject matter expertise to the completion of Clinical Evaluation Reports and Plan, Post Market Clinical Follow Up, Summaries of Safety and Clinical Performance, Post Market Surveillance, Risk Management Reports as part of the ongoing proactive and reactive reviews of quality and safety.
• Provide input and update the Global Harms Reference that will be used for the basis of severity risk
• Provide subject matter expertise to the creation and maintenance of
  
  
  

Process Failure Mode and Effects Analysis (PFMEA), Design Failure Mode

and Effects Analysis (DFMEA), Use Failure Mode and Effects Analysis (UFMEA) and Hazard Analyses for both new and existing devices.

• Responsible for UFMEA and the conversion of Hazard Analyses across the entire portfolio to Risk Assessment and Control Tables, with increased complexity to provide detailed description of the harms severities and probability of harm resulting in different severities.
• Coordinate with Regulatory Department regarding the proper handling of complaints, customer or product failures and safety and efficacy issues
  
  
  

Research and Development Support

• Participate as part of the Concept to Commercialization process to
  
  
  

provide subject matter expertise to multiple New Product Development

Projects. This extends to ongoing maintenance in Sustaining

Engineering both for the investigation of complaints and Cost Improvement Projects.

Mergers and Acquisitions, Legal Support

• Provide clinical input to the Due Diligence process as part of the M&A Team, and to Legal in relation to a wide range of issues.
  
  
  

Sales & Marketing Support

• Provide education and training around the safe and effective use of the company’s devices to the sales and marketing teams.
• Provide congress/tradeshow support. Answer questions at exhibitions, develop and give presentations, staff medical booth, meet thought leaders and participate in customer events. Further scientific communications domestically and internationally.
• Lead the development and enhancement of relationships and interactions with key opinion leaders and societies. Develop peer-level relationships and cooperation with external experts and other important decision makers in a consistent way, aligned with the overall company strategy and objectives.
  
  
  

Education / Experience Requirements

• Doctor of Medicine (MD) or corresponding international medical degree equivalent required. Prefer specialty in Anesthesiology, Critical Care, Surgery, Emergency Medicine or other acute medical specialty.
• Minimum of 5 years of clinical experience practicing in the healthcare environment required
• Previous experience in a leadership position, managing and developing teams required
• Experience in literature identification and analysis required
• Regulatory experience preferred
• Clinical and Medical Affairs experience preferred
  
  
  

Specialized Skills / Other Requirements

• Strong understanding of medical device market needs and current offerings
• Ability to critically analyze, interpret and summarize clinical data
• Ability to network and partner with customers and thought leaders
• Excellent interpersonal communication (written and verbal) and presentation skills
• Effective time-management and organizational skills including the ability to coordinate and prioritize multiple projects simultaneously.
• High attention to detail and the ability to adapt to shifting priorities
• Established track record of building and maintaining relationships with internal and external customers.
• Must be scientifically oriented with strong research, logic and reasoning ability
• Demonstrated ability to conduct business in an ethical manner
• Ability to read, understand and abide by company procedures.
• Capable of comprehending large amounts of scientific content and
  
  
  

the ability to define problems, collect data, establish facts, draw valid

conclusions and report on findings concisely.

• Ability to work successfully in a home office environment
• Requires the ability to travel a minimum of 50% including overnight stays and ability to travel internationally.
• Advanced skills in Microsoft Office Suite including Word, Excel, PowerPoint, Outlook etc.
• Ability to develop and foster relationships with KOL’s and key business stakeholders
• Pro-active and results oriented
  
  
  

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