Regulatory Affairs Specialist

Job content

Do you want to work in a big medical devices company? Do you have more than 4 years experience in Regulatory Affairs ? You should then read the following lines!

Our client, based in Solothurn, is looking for a Regulatory Affairs Specialist for a mission 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.).

Position 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

• 5 years of experience in European Medical device industry especially with regulatory, quality or engineering
• Strong knowledge of
• ISO 13485 and ISO 9001, QSR
• Medical Devices applicable requirements, especially Council Directive 93/42/EEC and Regulation 2017/745, as they pertain to technical documentation
• MEDDEV guidance documents applicable to Medical Devices products and processes
• Reasonable knowledge of
• FDA requirements
• 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.