Regulatory Affairs Manager

Company: Envista Holdings Corporation
Location: Yorba Linda
Posted on: January 7, 2022

Job Description:

Nobel Biocare is an innovation leader in the field of implant-based dental restorations. We offer a dynamic and inclusive environment that fosters creativity and collaboration within our global workforce. We strive to provide the highest-quality implant solutions and workflows, enabling our customers to deliver optimal patient outcomes, while fostering practice growth. We embrace our position as a leader in the premium segment and uphold the highest standards in the dental industry. With a commitment to developing our talented workforce, Nobel Biocare is a great place to build your career. For more information about Nobel Biocare, visit **Job Description:**Successful incumbent will:+ Develop and provide independent regulatory guidance to project teams in terms of strategy, premarketrequirementsand related submission to support optimal timelines and required compliance levels for product development and compliance projects.+ Authorizing and maintainingEUtechnical files, significant notifications, primarily US registrationsand US510(k) submissions.+ Ownership of regulatory elements of product development and design control required for market access to EU, US & CA including ensuring consistency in classifications,strategiesand documentation.+ Monitor closely and provide guidance and awareness of guidelines, regulations, changes in the marketplace and regulator positions and other information relating to global regulatory compliance for the assigned market.+ Supportthecreation and maintenanceofstandard operating procedures, work instruction and templates for technicalfiles, significant notifications,primarily US 510(k) submissions.+ Provide regulatory guidance,perform assessmentsand regulatory implementation ofproductchange requests.+ Review and approval of product related labeling, IFUs and marketing material and associated claims Supporting standard committee work including review of gap analyses.+ Provide training to Nobel Biocare associates on general and specific US processesand requirements.+ Consistently monitoring near misses and nonconformities lessons learnt and implementing measures to correct to prevent re-occurrence.+ Release of products to markets.+ Act as US Agent for Nobel Biocare.**Job Requirements:**Job Requirements:+ Bachelors Degree required+ Minimum5years' experience in regulatory affairs within medical device industry.+ Experience in interaction with regulators and government agenciesand tradeassociations,particularly with US authorities.+ Experience with Software medical devices.+ Experience in preparation, submission of US regulatory files and interface with FDA during review process+ Experience of devising regulatory strategies and conductingimpactassessments.+ Experience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures.PREFERRED SKILLS:+ Experience in dental field highly preferred+ Experience in preparing, supporting notified body audits including technical file and QMS audits and FDA inspections.+ Experience in developing and reviewing as well assuring required compliance of design control and associating technical documentationandpreparation of technical files required, and design dossier an advantage.+ Experience with state licensing\#LI-CY1IND123**Operating Company:**Nobel BiocareEnvista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: compliance/posters/pdf/eeopost.pdf.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 KaVo, Kerr, Nobel Biocare, Implant Direct and Ormco, partner with dental professionals to help them deliver the best possible patient care.Envista separated from Danaher as 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 .

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