Position: Associate

Job type: Full-time

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Job content

Do you have experience with regulatory affairs in a medical device environment ? You should then read those lines!

For our client, a big player in the medical device industry, we are looking for Junior Regulatory Affairs Specialist.
  • Start date: Asap
  • Length: until end of december, with likely extension until end of 2022
  • Location: Zuchwill
Tasks
  • Ensure 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
Profile
  • You have 1-2 years of experience in European Medical device industry especially with regulatory, quality or engineering
  • 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
  • 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
  • You have a degree in life sciences or engineering is required. Bachelor’s (minimum 3 years’ experience) or Master’s (minimum 2 year of experience). An advanced Degree (PhD with 1-2 years of experience) is preferred.
  • You are familiar with Technical Documentation structure according to STED required
  • You are a teamplayer, who can work in multi-functional and multi-national teams
  • You have strong interpersonal and diplomatic skills
  • You have strong analytical, planning and organizational skills and are able to set priorities
  • You have excellent customer service, interpersonal, communication and team collaboration skills
  • Some flexibility in working hours is required
  • You are fluent in English, German would be a plus.
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Deadline: 10-05-2024

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