Danaher Corporation RA Specialist in Bioggio, Switzerland
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
This position is responsible for assisting in the preparation and submission of domestic and/or global product registrations. The candidate must have a basic working knowledge of domestic and/or international medical device regulations, including 510k and international registration dossier submissions
Responsible for assisting in the preparation and compilation of domestic and international product registration submissions, with guidance. This includes, but is not limited to, 510ks, international dossiers and CE technical files.
Responsible for agency establishment registrations and device/drug listings.
Assist with the preparation and compilation of regulatory information requested during government audits/inspections, such as with FDA, Health Canada and Notified Body.
Support domestic and international field corrective actions and adverse event reporting.
Prepare monthly status reports, Key Performance Indicators (KPI) for Regulatory Affairs Management.
Perform special projects as needed
This job has no supervisory responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Bachelor's Degree (BA/BS) from four-year college/university or equivalent.
One to two years related experience and/or training preferred; or equivalent combination of education and experience
Sounds experience in MDD compliance. MDR knowledge is a plus.
At least 1-2 years’ experience of working in Regulatory Affairs Management within a MedTec company biopharmaceutical or biotechnology areas
Language Skill: fluent in English and Italian
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to read, analyze, and interpret regulation requirements.
Ability to effectively present information to peers.
Good prioritizing, organization, interpersonal, communication and analytical skills;
Must have the ability to work in a team-oriented environment and is able to meet tight deadlines. Building internal working relationships with all department levels. In the discretion of RA management, handles routine interactions with FDA and other regulatory agencies
Work independently with minimum supervision, across multiple geographics and functions;
Minimal experience in adverse event reporting and/or field corrective actions preferred
Good computer skills (MS Office);
Able to work in an high demanding environement and in a matrix organization
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
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 applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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: EMEA-Western Europe-Switzerland-Ticino-Bioggio
Req ID: KAV002419