Beschreibung
Regulatory Affairs Manager - 12 months contract - Switzerland - office basedOVERALL RESPONSIBILITIES:
Support MDR compliance execution work by creation/update Technical Documentation of existing devices to comply with MDR requirements
POSITION DUTIES & RESPONSIBILITIES:
- 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
- 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
PROFESSIONAL EXPERIENCE REQUIREMENTS:
Minimum of 5 years of regulatory experience in European Medical device industry
Strong knowledge of ISO 13485
Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) )
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
Strong knowledge and skills in MS Office
Familiarity with Technical Documentation structure according to STED required
Expertise in Windchill PLM and Agile e6 PLM System
Experience in SAP query and report development
Michael Bailey International is acting as an Employment Business in relation to this vacancy.