Junior Regulatory Affairs Specialist (m/f/d)

REFERENCE NUMBER:

551948/1

MY DUTIES:

- Support the internal 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 Note to files, as applicable, as well as country registrations on a world-wide basis, as appropriate
- 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

MY QUALIFICATIONS:

- Profound 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
- B.Sc. / M.Sc. or PhD in life sciences or engineering
- English spoken and written; German would be a plus

MY BENEFITS:

- A very renowned company
- Dynamic and innovative market environment
- Interesting tasks in a multinational environment

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.