The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
KaVo Kerr is a cohesive organization comprised of two global leaders, united to provide dental excellence and serve as a single premier partner for the dental community. KaVo Kerr operates with a common vision inspiring and helping our customers, their patients and our own associates realize their potential. KaVo Kerr offers solutions for endodontics, restoratives, treatment units, infection prevention, imaging, rotary and instruments.
Operating Company: KaVo Job Description:
The Kavo Senior Regulatory Affairs Specialist will be responsible for the appropriate licensing and legal compliance required for the distribution of medical products domestically, regionally, and globally, in conjunction with marketing forecasts and plans. This role will require the combined knowledge of scientific, legal and business issues, to enable products to be distributed by DITC in accordance with required regulations. The incumbent will advise on and co-ordinate the approval and registration of DITC products as required. The Senior Regulatory Affairs Specialist will act as the liaison linking DITC and its products with regulatory authorities, including the US Food and Drug Administration (FDA), local and state agencies and regulatory authorities worldwide.
PRIMARY DUTIES & RESPONSIBILIITIES:
Work with product development teams to ensure that the company's products comply with the US Food and Drug Administration (FDA), local and state agencies and international regulations for areas the products are intended for distribution.
Maintain current knowledge regarding applicable international legislation, guidelines, and standards.
Maintain current knowledge of the company's range of products.
Collect, organize and maintain a wide range of information pertaining to the safety, efficacy, and/or substantial equivalence of the company’s products.
Develop and write clear justifications and explanations for new product licenses and license renewals.
Work with specialized computer software and resources.
Review, advise and recommend changes to product labels, work instructions, and user manuals to ensure ease of use and regulatory compliance.
Interpret design, test, and validation data and work within the organization to resolve any issues needed for successful registration/reregistration.
Advise and support engineers and management on regulatory requirements.
Work with project teams and colleagues involved with the development of new and changed products to advise them on regulatory/licensing.
Develop and maintain excellent working relationships with regional Regulatory Affairs teams, dealers and distributors throughout the world to ensure their assistance and cooperation on regulatory issues including licensing, registrations, complaint issues/reports, new/emerging regulatory requirements, recalls, withdrawals, and notifications.
Help maintain the company’s quality system to reflect current requirements and state-of-the-art.
Assist/support/participate, as appropriate, with regulatory inspections and third-party audits.
Review Company’s practices, provide advice and propose changes/improvements to systems and processes.
Liaise with regulatory authorities on issues relating to submissions, approvals or clearance of the company’s medical devices, as needed.
Maintain systems and ensure timely submission of licenses and applications to authorities, adhering to strict deadlines.
Assist Engineering and/or other functional groups in prototype development, evaluation and documentation.
Other duties as assigned.
Bachelor’s of Science degree in a Science, Engineering or a Technical field.
5+ years of related experience in the Medical Device industry.
Ability to analyze and assimilate data including engineering drawings, specifications, labeling, statutory and regulatory requirements.
Proficient use of computers, MS-Office (Word, PowerPoint, and Excel knowledge required).
Must be able to work in a standard office environment.
Some travel may be required.
Knowledge of EU MDD and MDR rules and regulations.
Experience with imaging systems and software.
Superior written, verbal, interpersonal communications.
Self-motivated and able to work with minimum supervision.
Internal Number: R5005693
WHO WE ARE
Our roots run deep.
Envista is a global family of three operating companies and more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its partners deliver the best possible patient care through industry-leading products, solutions, and technology.
Envista separated from Danaher as an independent entity in 2019, bringing its proven business system methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, innovation, and deep customer focus. Envista is now one of the largest global dental products companies, with significant market positions in some of the industry's most attractive segments. Our comprehensive portfolio spans innovative dental implants and treatment options, orthodontics, and digital imaging technologies.