Danaher Corporation Sr. Regulatory Affairs Specialist in Hatfield, Pennsylvania
Danaher Company Description
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.
Essential Duties and Responsibilities: * 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 customer practices; * 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 dealer 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 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; * Work with engineering to specify storage, label and package requirements; * Assist Engineering and/or other functional groups in prototype development, evaluation and documentation; * Performs other duties and tasks as assigned by management. * Other duties as assigned
_REQUIREMENTS:_ * BS degree in a technical field * Minimum of 2 years of Regulatory Affairs experience or MS degree in Regulatory Affairs _PREFERRED SKILLS:_ * Proficient use of computers, MS Office (Word, Excel & PowerPoint) * SAP experience desired; RAC certification highly desired. * Superior written, verbal, interpersonal communications * Strong interpersonal communications, ability to lead teams and to work within teams; * Goal oriented, results driven * Ability to organize information and present to a wide array of audiences; * Ability to analyze and assimilate data including engineering drawings, specifications, labeling, statutory and regulatory requirements; * Self-motivated and able to work with minimum supervision
Danaher Corporation and all Danaher 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: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. #LI-CY1 IND-KAV1
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #144 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: KaVo Kerr
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-PA-Hatfield
Req ID: KAV003459