CER Technical Writer

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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. 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 (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly

Technology?

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About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

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