Emploi: lcm regulatory affairs support:Randstad.chJob description:
job detailspublié . 17. novembre 2021 lieu . solothurn, soleure secteur . life sciences type d'emploi . contract référence . 16786 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 more than 2 years experience in Regulatory Affairs? You should then read the following lines! Our client, based in Solothurn, is looking for a Life Cycle Management RA support for a contract until the end of 2022. OVERALL RESPONSIBILITIES Support the LCM Regulatory Affairs group in creation and maintenance of technical documentation, supporting compliance to ? European Council Directive 92/42/EEC or Regulation 2017/745, as applicable, ? US FDA 510(k) submissions or Notes to file, as applicable, ? As well as country registrations on a world-wide basis, as appropriate. in the context of Life Cycle Management projects (e.g. change of manufacturing process and/or equipment, change of manufacturing site, etc.). situation DUTIES & RESPONSIBILITIES ? Ensuring that the company's products comply with the regulations set up by government agencies ? Advising engineering and other support functions, as well as manufacturing on regulatory requirements ? Assisting with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining any required regulatory activities ? Creating, reviewing and maintaining regulatory related technical documentation ? Supporting maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals ? Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts on a global scale ? Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed; assisting in review of international product technical documents, marketing and labeling materials ? Supporting team's daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations ? Providing progress of work-plans and the status of key project deliverables EXTENDED DUTIES ? Follow the applicable 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 PROFESSIONAL EXPERIENCE REQUIREMENTS: ? Strong knowledge of o ISO 13485 and ISO 9001, QSR o Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation o MEDDEV guidance documents applicable to Medical Devices products and processes ? Reasonable knowledge of o FDA requirements o registration requirements in further global markets would be an asset ? Strong understanding of Risk Management process, label and labeling, change management is desired ? International experience preferred ? Proven exceptional written and oral communication skills EDUCATIONAL REQUIREMENTS ? Bachelor's (minimum 3 years? experience) or Master?s (minimum 2 year of experience) Degree in life sciences or engineering is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred. OTHER REQUIREMENTS ? Familiarity with Technical Documentation structure according to STED required ? Teamwork oriented, within a multi-functional and multi-national team ? Strong interpersonal and diplomatic skills ? Customer / service orientation ? High analytical, planning and organizational skills; able to set priorities ? Strong knowledge and skills in MS Office Do not waste any minutes, apply now! We are looking forward to receiving your application. Skills:
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