Danaher Corporation Regulatory Affairs Manager in Kloten, Switzerland
Danaher Company Description
Nobel Biocare is a world leader in the field of innovative implant-based dental restorations – from single-tooth to fully edentulous indications. Nobel Biocare offers you a great place to work by giving you the opportunity to grow and be recognized for your effort and achievements.
In this function the position is responsible for all RA deliverables linked to the management of new product development activities with focus on Implant systems.
The RA Manager will be responsible for developing and executing regulatory strategies for assigned projects while focusing on the main markets, i.e. EU, US, CAN and AUS. This will include the creation, review and/or approval of documents of the design control process, development of the techinical file and summary of technical documentation. He/she will be responsible for monitoring submission timelines and timely responses to requests by notified bodies or competent authorities. It also includes constant development/ improvement of product development and RA processes.
The RA manager will support international product registration by consulting the responsible RA mangager for international projects.
Monitoring of legislative environment in main markets, i.e. EU, US, CAN and AUS and define and maintain an overview of the regulatory requirements and changes in the areas if applicable.
Assessing, approval and release of communication material (IFU, leaflets, brochures). Train and assist other departments to ensure continued compliance and timely market release.
- Development and execution of regulatory strategies for assigned development projects on implant systems
- Support of product development in cross functional teams
- Creation, review and/or approval of documents of the design control process
- Accountable for regulatory compliance
- Support international product registration
- Assessment, approval and regulatory implementation of change requests
- Review and approval of product related labeling and marketing material
- Support SAP based reporting systems
- Monitoring legislative environment in relevant markets
- Training internally on relevant procedures and requirements
- Understanding of regulatory requirements, applicability and implementation in practice
- Understanding for product development process and principles of design control
- Understanding for quality system requirements
- Development, review and release of all documents required for technical files
- Interpersonal skills and multitasking
- Work in SAP and office and Google based programs
- Technical or scientific background, university degree is an advantage
- Good Knowledge of medical device legislation EU ,US, AUS and CAN and corresponding guidelines
- Good knowledge of product development processes in MD industry
- Good knowledge of quality system requirements such as ISO 13485 and FDA’s 21 CFR Part 820
- Fluent in English, further languages are an advantage
- Highly organized and able to work under strict time lines
- Strong interpersonal skills and proactive working attitude in a international matrix organisation
- Excellent writing and communication skills
- Experience in preparation for notified body audits and FDA inspections
- Experience in managing cross functional projects and teams
- Minimum 3 to 5 years experience in regulatory affairs within the Medical Device Industry
- Experience with EU, US, AUS and CAN medical Device regulations
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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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: Nobel Biocare
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Switzerland-Zurich-Kloten
Req ID: NOB002572