Kelly Science, Engineering, Technology & Telecom is hiring : CER Technical Writer

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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. Develops, implements and manages 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.

Actively partners 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

Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans, and a transit spending account.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status.

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