Kelly Services Clinical Evaluation Report Writer - Orthopedic in Irvine, California
Kelly Services is seeking candidates for a Technical CER Writing opportunity in the USA. Candidates must have previous Clinical Evaluation Report (CER) orthopedic writing experience for surgical mesh, endoscopic devices or sutures. This position is currently budgeted for two years with possibility of extending.
The Technical Writer is a shared service team member supporting and executing the Clinical Evaluation Report (CER) and Safety Surveillance Report (SSR) processes for the assigned therapeutic areas within the medical device businesses within his/her scope of responsibility.
POSITION DUTIES & RESPONSIBILITIES:
Responsible for the writing of Clinical Evaluation Plans
Responsible for compliant writing of CERs in accordance to local procedures, the client’s guidelines and regulatory requirements
Responsible for ensuring compliant creation of SSR reports 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
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 CER regulatory requirements, evidence generation, and CER document creation is required
Writing experience with either joints and spines or general ortho-like instruments, pins and screws is required
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 is preferred
Regulatory/Notified Body audit experience is preferred
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
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With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
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AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
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