To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

• We are a global healthcare leader that helps people live more fully at all stages of life.
• Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
• Our 103,000 colleagues serve people in more than 160 countries. 
  
  Job Description: 

• In this role, you will provide technical and strategic expertise at the post-market phase of product life cycles. Reviews/manages Post-Market Surveillance (PMS) Plans, Periodic Safety Update Report (PSUR) and PMS Report and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines.   
• With minimum supervision, collaborates with medical writers to create and maintain PMS plans, PSURs and PMS Reports for our products.
• Identifies appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references.  
• Creates or participates in the PMS Plan/PSUR/PMS Report timelines. Actively manages timelines and project delays/risks, develops scenarios and recommendations for management. Ensures project expenditures are within budgetary guidelines 
• Facilitates communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, Complaints Management, Quality Engineering, Clinical Affairs, Project Management, as well as external vendors such as contract medical writers. 
• Maintains update-to-date understanding and experience of clinical / PMS data and risk management. 
  
  Minimum Education: 

• Bachelor's degree required; advanced degree preferred. Degree in the sciences, medicine, or similar discipline highly preferred.
• Minimum of 5+years of related work experience with an understanding of specified functional area, or an equivalent combination of education and work experience.
• May consider candidates with less experiences. 
  
  Minimum Experience / Training Requirements: 

• Knowledge of PMS Plans / PSURs / PMS Report in accordance with the EU Medical Device Regulations (MDR 2017/745) 
• Knowledge of CERs and related documents in accordance with MDR 2017/745.  
• Understanding of regulations, standards and guidelines related to medical devices clinical studies and quality systems, including: MDR 2017/745; MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev.  4; ISO 14971; ISO 14155; ISO 13485. 
• Effective written, verbal and presentation skills in the area of technical/clinical applications. 
• Familiar with IMDRF terminology/codes and adverse event reporting is preferred 
• Project management experience is preferred. 
• Experience in post-market surveillance, risk management, clinical research, or regulatory affairs in medical device or pharmaceuticals industry 
• Demonstrated ability to identify and adapt to shifting priorities and competing demands. 
• Highly-developed interpersonal skills, and strong attention to detail.