specialist 2, regulatory affairs à Zuchwil

Audrey Bisch, Bâle Professionals Health Care & Life Sciences
type d'emploi
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job details

zuchwil, soleure
life sciences
type d'emploi
audrey bisch, bâle professionals health care & life sciences
058 201 55 50

description du poste

Do you want to work in a big medical devices company? Do you have experience in Regulatory Affairs for Medical Devices? You should then read the following lines!


Our client, based in the Solothurn area, is looking for a Regulatory Affairs Specialist for a contract until the end of the year with possibility of extension.


Your Responsibilities: 

• Support the LCM Regulatory Affairs group in preparation, uploading and maintenance of technical documentation for submissions to the UK CABs for obtaining UKCA approval for the GB market• Support of additional regulatory affairs activities as directed.• Ensuring that the company's products comply with the regulations set up by government agencies• Creating, reviewing and maintaining regulatory related technical documentation• Assisting with reviewing of product and process documentation to ensure compliance with change control requirements to aid in determining any required regulatory activities• Advising engineering and other support functions, as well as manufacturing on regulatory requirements• 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• Working with cross-functional teams to obtain relevant information and subsequent review of submission content as needed, assisting in review of product technical documents, marketing and labeling materials• Capturing and verifying regulatory product characteristics to support logistic and supply chain efforts• 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• 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 ariseYour Profile:• 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• 3-5 years of experience in European Medical device industry especially with regulatory, quality or engineering• Strong knowledge of:o ISO 13485 and ISO 9001, QSRo Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentationo MEDDEV guidance documents applicable to Medical Devices products and processes• Strong understanding of Risk Management process, label and labeling, change management is desired• Knowledge of registration requirements in further global markets would be an asset• Familiarity with Technical Documentation structure according to STED required• Strong knowledge and skills in MS Office• 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   

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.