Beschreibung
Regulatory Affairs Manager - Medical Devices 4 months contract - SwitzerlandWe have a new opportunity for experienced RA manager to support MDR compliance execution activities for the Powertools business and review and compile Technical Documentation for existing devices to comply with MDR requirements.
POSITION DUTIES & RESPONSIBILITIES
* Identify, create and/or update 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, Table of Contents, Declaration of Conformity, and labeling.
* Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches inclusive of site transfer activities.
* Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
* 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
PROFESSIONAL EXPERIENCE REQUIREMENTS:
* AT least 5 years of experience in European Medical device as regulatory affairs specialist
* Strong knowledge of ISO 13485 and ISO 9001, QSR,
* understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) )
* MEDDEV guidance documents applicable to Medical Devices products and processes
* 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
* Strong interpersonal and diplomatic skills
* Team work oriented, within a multi-functional and multi-national team
The role is based in Switzerland and allows home based working flexibility, the contract has further extension possibility
Michael Bailey International is acting as an Employment Business in relation to this vacancy.