Kelly Science, Engineering, Technology & Telecom · 3 hours ago
CER Technical Writer
United States
Full-time
Remote
Entry, Mid Level
$80K/yr - $90K/yr
2+ years expKelly Science, Engineering, Technology & Telecom is seeking a CER Technical Writer with experience in the medical device industry. The role involves writing Clinical Evaluation Plans and Reports, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.
Staffing & Recruiting
Hiring Manager
Kellie Pharr
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
BA, BS, or BSN is required
A minimum of 2 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
Preferred
advanced degree
Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods
Regulatory/Notified Body audit experience
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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