CER Technical Writer

The CER Technical Writer must have experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation to be considered. This is a remote position to work out of your home office full time.

POSITION DUTIES & RESPONSIBILITIES:

• Responsible for the writing of Clinical Evaluation Plans
  

• Responsible for ensuring compliant creation of Clinical Evaluation Reports, Plans and SSCP reports within this business in accordance with local procedures, the client’s guidelines and regulatory requirements
  

• Ensures the CER and SSR files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed. S/He will develop, implement and manage an effective communication model for CERs/ SSCPs with cross functional business partners
  

• Assists in the development of schedules to ensure operating company CER/SSCP timelines are met
  

• Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
  

• Supports and at times acts as an SME during audits and inspections pertaining to CER/SSCP processes and reports.
  

• Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, Clinical Affairs and Regulatory Affairs relating to the CER/SSCP process

EDUCATION & EXPERIENCE REQUIREMENTS:

• BA, BS, or BSN is required; advanced degree is preferred
  

• A minimum of 3 years of related job experience is required for this position
  

• Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation is required
  

• Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common biostatistical methods is preferred
  

• Regulatory/Notified Body audit experience is preferred

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