Vita Global Sciences, a Kelly Company · 6 hours ago
CER Technical Writer
United States
Contract
Remote
Entry, Mid Level
2+ years expVita Global Sciences, a Kelly Company, is seeking a CER Technical Writer to work remotely. The role involves writing Clinical Evaluation Plans and Reports, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to maintain quality and efficiency in the CER/SSR processes.
AnalyticsData VisualizationInformation Technology
Responsibilities
Responsible for the writing of Clinical Evaluation Plans
Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance to local procedures, the client’s guidelines and regulatory requirements
Responsible for ensuring compliant creation of SSR reports within this business in accordance to 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/SSRs with cross functional business partners
Assists in the development of schedules to ensure operating company CER/SSR 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/SSR processes and reports
Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process
Qualification
Required
Experience within the medical device industry
Knowledge of clinical evaluation report regulatory requirements
Evidence generation
CER document creation
BA, BS, or BSN is required
A minimum of 2 years of related job experience is required for this position
Preferred
Advanced degree is preferred
Demonstrated knowledge and experience in quality regulatory compliance
Complaint handling
Adverse event reporting
Medical device risk management processes
Experience with common bio statistical methods
Regulatory/Notified Body audit experience is preferred
Company
Vita Global Sciences, a Kelly Company
From Research To Reality.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Tim Southwick
President / Founder at Vita Global Sciences
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