Datwyler’s high-tech elastomer components make a vital contribution to the safety, reliability and functionality of critical systems in billions of syringes and coffee capsules, in every second vehicle worldwide, and in energy-related applications. Datwyler serves highly regulated and technologically demanding markets, such as Healthcare, Automotive, Food & Beverage and Industry.
With around 7,500 employees and 25 production sites on four continents, we work closely with customers from concept to series production. Our employees are at the heart of Datwyler. Guided by Mastery, Impact and Respect, we continuously improve, focus on meaningful results and collaborate with trust and openness.
Become part of our team as a Regulatory Affairs Specialist.

Job Purpose

The responsibility of the Regulatory Affairs Specialist is to support customers’ requests regarding referencing of Datwyler Drug Master Files for drug approvals, facilitate washing validations, ensure provision of standards, etc.

Main Tasks & Responsibilities





• Responsible to assess customers requests for Letters of Authorization (LOA) to reference Drug Master Files (DMFs)
• Issue LOA drafts for US-FDA, Health Canada and NMPA China.
• Maintain LOA data base, prepare analysis and share with the sales teams as required
• Prepare weekly data packages for DMFs & support RA Manager for the annual reports of all DMFs
• Responsible for the availability of annual washing validation reports of all healthcare sites, review reports and transform into submissions formats.
• Arrange samples and testing data required for submission
• Support RA Manager in preparation of dossiers and preparing response to the Health Authorities
• Manage timely notarization and legalization of quality certificates/ documents
• Maintain ISO database & support Datwyler employees in obtaining working copies of standards
• Track list of standards for updates / revisions & support implementation of revised standards regarding CDS & COAs
• Demon

📌 Regulatory Affairs Specialist (Satara)
🏢 Dätwyler
📍 Satara