Join Tecan! Join the market leader! Work in an international and dynamic environment, share our success! Tecan is a leading company in the fast growing global life science supply industry. We are specialized in the development, production and distribution of automation solutions for laboratories in the market segments life sciences, clinical diagnostics and forensics.
You will have the unique opportunity to make an active contribution to the successful further development and growth of Tecan. To complete our Regulatory Team in Männedorf/Switzerland we are seeking a highly accomplished
Regulatory Manager In this role you are responsible for supporting Tecan's product design and development activities and initiatives. The Regulatory Affairs Manager will be responsible for ensuring compliance with European, FDA and other applicable international regulations and requirements for the design and development of general purpose and IVD devices, and provide general regulatory support to the organization. Key Duties: This position will be responsible for ensuring regulatory compliance of Tecan's product realization and lifecycle process for the company's growing line of products and it will also support ongoing product conformity requirements.
Ensures that national and international compliance regulations are met for the design and development of a variety of products, including FDA's Quality System Regulation (21 CFR Part 820), ISO 13485, European Directives / Regulations, and others
Responsible for ensuring that the required documentation is properly assembled and maintained per quality system processes and procedures
Provides support to the company in the design, development, manufacture, and improvement of regulated products
Collaborates closely with the R&D department as well as with sales team
Develops product approval strategies in collaboration with the sales areas
Company representative for international regulatory authorities
Vigilance Reporting and Post Market Surveillance
Reviews and approves Marketing Material
Degree in microbiology, chemistry, medical or other scientific discipline or equivalent experience and 5+ years in Regulatory Affairs
3-5 years of experience in the medical devices industry or related regulated products is required; experience regarding medical device or IVD design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the IVD Directive 98/79 EC, as well as ISO 13485 requirements is essential
Experience supporting medical device/IVD regulatory submissions is an essential element of this position
Experience with recalls, corrections, removals and MDRs is preferred. Knowledge of the international registration process would be a plus
Goal oriented with a structured working pattern
Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
Outstanding social skills, excellent communication skills, a solution-oriented mindset are all essential to fulfill this role successfully
Fluency in English as well as good level in German
If this brilliant Regulatory Affairs position for a fantastic company interests you, and you truly believe that you have what it takes to successfully meet the demanding requirements - please send your application online.