Regulatory Affairs Specialist II

Waters is seeking a Regulatory Affairs professional to support growth in the IVD product portfolio through regulatory support for new products. The role involves preparing and submitting filings, conducting international registrations, supporting global regulatory intelligence, and providing guidance on product labeling and changes. The position requires a strong understanding of regulatory frameworks such as the European IVDR and Chinese regulations.

Requirements

• A bachelor’s degree or equivalent experience is required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering.
• Experience in regulatory affairs in the In Vitro Diagnostic Medical Device environment, or equivalent
• Knowledge and application of 21 CFR 820 and ISO 13485
• Knowledge and application of the European IVDR is required.
• First-hand experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications, & technical files for US & EU regulatory approval, preferably for clinical IVD products
• Proficiencies in English and verbal and written communication skills
• Strong organizational and communication skills
• Strong ability to work in a global function
• Strong ability to work with individuals/teams distributed across many different locations and cultures
• Strong ability to work with individuals/teams dispersed across many different locations and cultures

Benefits

• Competitive salary
• Comprehensive health insurance
• Paid time off
• Retirement plan