Life cycle management RA support

For our client in Solothurn area, we is looking for a Life cycle management RA support.

• 
  contracting position (3 up to 1.5 years)
• 100%
• asap

Responsibilities

• Support the internal Regulatory Affairs group in creation and maintenance of technical documentation
• 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

Your 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.
• 1-2 years of experience in European Medical device industry especially with regulatory, quality or engineering
• Knowledge of ISO 13485 and ISO 9001, QSR AND Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation AND MEDDEV guidance documents applicable to Medical Devices products and processes
• Knowledge of FDA requirements AND 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
• Familiarity with Technical Documentation structure according to STED required
• Team work 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
• Able to work on multiple simultaneous tasks with limited supervision
• Quick learner, motivated self-starter
• Excellent customer service, interpersonal, communication and team collaboration skills
• Able to cope with internal guidelines change management
• Some flexibility in working hours is required
• English spoken and written. German would be a plus.