Regulatory Affairs Manager (m/w)
To expand our current capabilities we are seeking a highly motivated
We are looking as soon as possible for a skilled individual with experience in the pharmaceutical / medical device industry. You will work cross functionally being responsible for the regulatory aspects of the CE labelling of our in-vitro diagnostic products. Excellent English and German verbal and written skills are mandatory (German native speaker preferred).
- Represent the regulatory affairs function and provide regulatory guidance and strategy for assigned products;
- Plan, prepare and manage regulatory documents and submissions during development and life cycle management for assigned products;
- Act as regulatory contact person for authorities, external partners and in-house functions;
- Creation and maintenance of technical files, design control, risk management
- Post market surveillance, vigilance reporting;
- Keep current with the regulatory and scientific environment and support the creation of standard operating procedures;
- Supervise employees, giving work direction and training;
- Support the quality management department;
- Reports to the Head of Quality Management.
- Degree in pharmacy, chemistry, biology, medicine or related discipline;
- At least two years experience as Regulatory Affairs Manager in a pharmaceutical / medical device or IVD company;
- Knowledge of ISO 13485, ISO 14971, IVDD regulations are required, prior experience with interacting with Competent Authority preferred;
- IVD CE-Mark Annex II, List A or B with Notified Body interactions desired;
- Experience in regulatory submission process of clinical studies favored;
- Laboratory experience is a plus;
- Organization and planning skills;
- Communication, negotiation and interpersonal skills;
- Ability to strategically plan, organize and manage multiple projects simultaneously;
- Track record of creativity and problem solving in projects;
- Sound knowledge of clinical study requirements;
- Project management skills / training.
Please send your application only by e-mail to firstname.lastname@example.org. Please indicate the job title in the header of your e-mail.
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Über NEO New Oncology GmbH
NEO New Oncology GmbH - a third-generation diagnostics company headquartered in Cologne - is part of Siemens Healthineers. The company was founded by reputable cancer scientists Prof. Axel Ullrich and Prof. Roman Thomas. Employing best-in-class NGS based cancer diagnostics NEO New Oncology supports oncologists and pathologists in finding the best possible targeted cancer therapies for their...Mehr über die NEO New Oncology GmbH