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수평: Associate
직업 종류: Full-time
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작업 내용
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
- 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
- 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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마감 시간: 10-05-2024
무료 후보 신청 클릭
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