Danaher Corporation Regulatory Affairs Specialist in Amersfoort, Netherlands
Danaher Company Description
Since 1960, Ormco, one of the many successful companies owned by Danaher Corporation, has been developing, manufacturing, and marketing a broad line of orthodontic appliances and related products for sale in the U.S. and abroad. Ormco provides orthodontists with brackets, wires, adhesives, and ancillary supplies used through the course of treatment.
Ormco believes the direct contact of its sales force with orthodontists facilitates the identification and verification of market trends and new product opportunities. Ormco works closely with orthodontists to improve existing products and develop new products primarily through its Champion programs in which selected orthodontists assist Ormco in designing, developing and ultimately educating users on new product and technique innovations.
This position provides Regulatory to the local organization and collaboration to Ormco organization on global level.
ESSENTIAL DUTIES AND RESPONSIBILITIES: * Ensure compliance with MDD/MDR. Execute registrations in collaboration with the US team when/if required. * Delivery of both simple and complex submissions throughout the product's life cycle from an EU regional perspective. To act as a key point of contact between the company and external companies operating in the EU and outside the EU. * Identify potential regulatory risks to the operational plans, and propose options to mitigate risks. Ability to work in a demanding environment with stretched goals. * Assure Quality compliance through maintenance of our QMS.
Most Important Qualifications and Competencies:
- A Bachelor’s degree or relevant proven experience in a Science-related discipline
- 3 - 5 years’ experience of working in Regulatory Affairs Management within a medical device producing company.
- Ability to read, analyze, and interpret regulation requirements.
- Ability to effectively present information to peers.
- Sound knowledge of MDD 93/42/EEC, MDR 2017/745 and Registration Process outside the EU such as Middle EAST and ASIA countries regulation will be a plus.
- Good prioritizing, organization, interpersonal, communication and analytical skills.
- Work independently with minimum supervision, across multiple departments and functions.
- Good computer skills (MS Office, SAP, Oracle).
- Basic knowledge of lean methods (5S, Kaizen).
- Able to work in a high demanding environment and in a matrix organization.
- Language Skill: fluent in English.
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 $16.5B in revenue last year. We are ranked #133 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.
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Netherlands-Utrecht-Amersfoort
Req ID: ORM001169