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1 job found in Nidwalden

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    • oberdorf, nidwalden
    • contract
    Do 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.
    Do 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.

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