Jicin, CZE
43 days ago
R&D Associate
**Job Description:** The R&D Associate prepares product and project documentation in compliance with the internal Quality System's procedures and applicable directives and standards (e.g., MDR; FDA 21 CFR 820; ISO 13485; ISO 14971). The R&D Associate is expected to lead small local projects. **Job Requirements:** **Responsibilities** Documentation: Develop and maintain detailed product and project documentation (protocols, reports), ensuring compliance with internal Quality System procedures and relevant regulatory standards. Labeling: Create, review, and update labeling redlines to ensure compliance with regulatory requirements and internal standards. Project Management: Lead small local projects from initiation to completion, ensuring timely delivery and adherence to project plans. Research and Development: Assist in the design and development of new medical devices and improvements to existing products. Regulatory Compliance: Ensure all documentation and processes comply with applicable directives and standards (MDR, FDA 21 CFR 820, ISO 13485, ISO 14971). Prepare documentation for regulatory assessment and cooperate with regulatory affairs. Collaboration: Work closely with cross-functional teams, including engineering, regulatory affairs, and quality assurance, to gather information and ensure documentation accuracy. Supervise internal and external testing activities. Communicate with external labs, consultants to support ongoing projects. **Requirements** Technical High School Diploma or equivalent in a relevant field (e.g., Engineering, Biomedical Sciences, Technical Writing). Technical Writing: Excellent writing skills with the ability to create clear and concise documentation. Regulatory Knowledge: Understanding of regulatory requirements and standards for medical devices is an advantage. Project Management: Ability to manage small projects, including planning, execution, and monitoring. Attention to Detail: High level of accuracy and attention to detail in all aspects of work. Analytical Skills: Ability to analyze data and technical information to support documentation and project development. Collaboration: Effective communication and teamwork skills to work with cross-functional teams. Organizational Skills: Organizational skills to manage multiple tasks and projects simultaneously. Technical Proficiency: Proficiency in using documentation management systems and software tools (e.g., Microsoft Office, Adobe Acrobat). Communication: Good communication skills, both written and verbal in English and Czech are required. **Operating Company:** Kerr Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .
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