CER Technical Writer Job Listing at Kelly Services in Raynham, MA (Job ID US3614451_BH9998468)

Description

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?

Looking to put your tech expertise to work on today's most intriguing, innovative, and high-visibility projects? By partnering with Kelly Technology, you'll gain direct connections to top companies around the globe. Our team creates expert talent solutions to solve the world's most critical challenges. In a world where change is the only constant, our extensive network of industry relationships and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, make an impact, and grow your tech career.

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.

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, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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