Teleflex develops and provides medical devices and healthcare solutions for professionals across areas including anesthesia, emergency medicine, and interventional cardiology. Its work combines product innovation with clinical education and customer support, helping healthcare teams deliver care and improve patient outcomes in a range of medical settings.
Associate Regulatory Affairs Specialist – 3-Year Contract, Onsite in Bülach, Switzerland | Teleflex
Support global regulatory assessments, documentation, and change registrations for medical devices at Teleflex. This onsite, three-year contract role covers highly regulated markets, including Europe, the United States, and Japan.
Description
- Evaluate design and manufacturing changes for regulatory compliance and determine their regulatory impact.
- Coordinate and contribute to global change assessments.
- Support related product and production lifecycle activities.
- Maintain regulatory records for international regulatory purposes.
- Assist with registering changes for Class II and III devices in Europe, the United States, Japan, and other highly regulated markets.
- Coordinate and submit responses to deficiencies raised by certification bodies and national authorities.
Requirements
- University degree in natural science, pharmacy, pharmacology, medicine, or engineering.
- At least two years of experience registering medical devices and assessing regulatory changes in Europe and other highly regulated markets.
- Proficiency with Microsoft Office and Adobe Acrobat.
- Dependable, communicative, and collaborative working style.
- Ability to work in multidisciplinary teams spanning R&D, Production, Quality, Marketing, and Clinical functions.
- Strong attention to detail, organization, and analytical capabilities.
- Ability to manage multiple concurrent projects, including urgent work with tight deadlines.
- Flexibility to adapt to changing programs and timelines.
- Fluency in English is required.
Benefits
- Equal opportunity employment.
- Application-process accommodations and support are available.
- Workplace culture focused on diversity and inclusion.