Kelly Services
Technical Writer_
Kelly Services, Brea, California, United States, 92821
**Technical Writer (Hybrid) - Brea, CA****Summary:**We are seeking a Technical Writer for a 6-month contract with expertise in the EU Medical Device Regulation (MDR), specifically focused on dental products. The successful candidate will be responsible for creating and updating 18 technical files to ensure compliance with the new EU MDR requirements. This role requires experience working with BSI auditors and the ability to interpret and apply complex regulations.**Details:**+ Pay: $35 - $38/hr+ Schedule: Hybrid+ Mon & Fri: remote+ Tues/Wed/Thurs: On-site+ Duration: 6 month contract**Responsibilities:**+ Create and update 18 technical files for dental products, including bands, elastics, passive self-ligating brackets, archwires, instruments, adhesives, stainless steel accessories, and coil springs, in accordance with EU MDR requirements.+ Ensure all documentation is compliant with current EU MDR regulations.+ Interpret and apply EU MDR regulations to ensure compliance across all technical documentation.+ Stay informed about changes in EU MDR regulations and guidelines and update technical files accordingly.+ Work closely with Engineering, Quality Assurance, and Regulatory Affairs teams to gather necessary information for technical file creation.+ Manage documentation related to clinical evaluations, risk management, and post-market surveillance.+ Translate complex dental product specifications into clear, precise, and engaging technical documentation.+ Ensure all documentation meets the quality and clarity standards required for regulatory compliance.+ Liaise with BSI auditors to ensure all technical files are prepared for audit and meet the required standards.**Qualifications:**+ Bachelor’s degree in a related field is required; an advanced degree is preferred.+ Proven experience as a Technical Writer in the medical device industry, with a preference for candidates with a background in dental products.+ Experience working directly with BSI auditors.+ Strong knowledge of EU MDR and other relevant medical device regulations.+ Proficient in MS Office and familiar with document management systems.+ Excellent written and verbal communication skills.+ Strong attention to detail and ability to produce clear, polished, and compliant documentation.+ Ability to work effectively in a fast-paced environment and manage multiple tasks within tight deadlines.\#P2As 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 (ykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.Why Kelly ® Science & Clinical?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About KellyWork 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.