• Identify, create, update, review and/or approve reference documents for technical documentation including, but not limited to design and risk documents, verification/validation documents, standards conformance, Clinical Evaluation Reports, General Safety and Performance (GSRP) Checklists, Instructions for use, labeling and Declaration of Conformity.
• As required, coordinate with various Technical file cross functional teams to make sure that data is aligned across the spectrum.
• Identify and adhere to policies, procedures and work instructions which support technical documentation activities
• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assist in review of international product technical documents, marketing and labeling materials
• Align and create technical documentation according to OneMD technical documentation structure proposed by the MDR team and/ or according to updated procedures by fulfilling RA deliverables according to project plan
• Support for routing and implementation of the remediated documents in PLM systems
• Support preparation of technical or design dossier documentation for submission to and review by Notified Bodies, as required
• Provide support for preparation activities for MDR compliance including, but not limited to data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned
• Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations
• Profound regulatory experience in European Medical device industry. Proficient knowledge of MDR strongly preferred
• Strong knowledge of ISO 13485
• Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)
• Reasonable knowledge of FDA requirements and possibly registration requirements in further global markets;
• Strong understanding of Risk Management process, label and labeling, change management is desired
• Proven exceptional written and oral communication skills in English
• Bachelor's or Master’s Degree in engineering or life sciences is required
• You will work in an international environment
Projektdauer: 12 MM
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