Emploi: lcm regulatory affairs support:Randstad.ch
. 17. novembre 2021
. solothurn, soleure
. life sciences
. 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 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.
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
? 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
? 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.
? 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.