Emploi: specialist 3, regulatory affairs:Randstad.chJob description:
job detailspublié . 09. décembre 2021 lieu . oberdorf, nidwalden secteur . life sciences type d'emploi . contract référence . 16855 contact . audrey bisch, bâle professionals health care & life sciences téléphone . 058 201 55 50 appliquer > description du posteDo you want to work in a big medical devices company? Do you have at least 2 years experience in RA for Medical Devices? You should then read the following lines! Our client, based in the Solothurn area, is looking for a CH - Specialist 3, Regulatory Affairs for a 1 year contract. Your Tasks: ? 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 ? Follow the quality standards and regulatory requirements ? Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times ? Resolving complex issues as they arise Your Profile: ? Master?s Degree in engineering or life sciences is required; ? 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) 2017/745) ? MEDDEV guidance documents applicable to Medical Devices products and processes ? Strong understanding of Risk Management process, label and labeling, change management is desired ? English fluent is mandatory (all documentation in English) Do not waste any minutes, apply now! We are looking forward to receiving your application. Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. Skills:
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