Regulatory Affairs Specialist - Barlev, Israel

Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solution offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY.

For over 25 years, MIS has been developing and producing advanced products and innovative solutions, aimed to simplify implant dentistry. Through state-of-the-art production facilities, MIS offers a comprehensive range of high-quality dental implants, superstructures, tools and kits, regenerative solutions and digital dentistry services and has now become part of the Dentsply Sirona family.

Regulatory Affairs Specialist

MIS by Dentsply Sirona is looking for Regulatory Affairs Specialist. In this role you will be working with various internal and external, national and international functions in order to develop, maintain and support the DRA strategy of the organization. . You will be integral part of RA team in Bar Lev (Misgav, Galil), Israel.

Key Responsibilities

• Preparation and filing of regulatory submissions for the registration of medical devices.
• Updating existing evaluations and technical files, including product risk management reports. Evaluation and approval of mechanical testing.
• Updating of technical files following changes and updates to the products.
• Provide deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for life-cycle management of products.
• Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
  

Requirements

• Degree in Engineering/Life Sciences/ Biotechnology
• Education in the field of quality - assurance/quality/engineering – advantage
• Experience in regulatory work in the field of medical device/pharmaceutical/ bio - advantage
• Very high level of English, written and verbal
• An additional language – an advantage
• Command of OFFICE and common computer applications
  

Dentsply Sirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona.

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For California Residents

We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes).

The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).

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