Job Description:

　　Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.

　　Key Responsibilities:

　　Gathering and prepare documents for new application submission in medical device process and include amendment documents for submit after received TFDA feedback in the deadline. (Pre-Submission and E-Submission)

　　Supporting to confirm label process with TFDA system.

　　Gathering and prepare documents for diagnosis of medical device. (Product not medical device in Thailand such as laboratory product etc.)

　　Gathering information on importing and selling medical devices under the importer and make a report to the TFDA.

　　Gathering and preparation of documents for permission to advertise with TFDA for support sales and marketing event.

　　Gathering and preparing documents for amendment request application with TFDA when information changed and meet the requirements that the TFDA is allowed to submit for amendments such as Software.

　　Supporting every renewal of the license of the master document. or new regulations of the TFDA.

　　Supporting and helping RA administration in general task.

　　Job Requirements:

　　Qualifications:

　　Bachelor’s degree or equivalentExperience:

　　Preferably minimum 1 year of experiences in regulatory affairs

　　Experience in medical device registration with Thai FDA company preferred; IVD, pharmaceutical or biologics would also be considered

　　Personal skills/Attributes:

　　Intermediate of English skill

　　A good team player

　　Hands-on and Detailed

　　Good communication and interpersonal skills

　　Demonstrated ability to deliver assignments on time

　　Proficient in Microsoft Office and Adobe Acrobat

　　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 .