This role serves as a senior individual contributor and regulatory subject matter expert for new product development, design changes, and lifecycle management activities, with emphasis on independent support of engineering product design projects, regulatory strategy, technical documentation, and technical areas such as biocompatibility, sterilization, packaging, labeling, process validation, test method validation, software validation, and verification and validation evidence. Builds, authors, reviews, andmaintainstechnical documentationcompliant withEU MDR 2017/745, including Annex II and Annex III documentation, GSPR evidence, risk management linkages, clinical and post-market surveillance inputs,clinical evaluation, verification and validation summaries, and technical rationale for conformity assessment.