Our client is an immunoassay provider focused on specialty diagnostics. The company has more than 30 years of experience in the development, manufacture and supply of immunoassays for routine diagnostics and research.

As part of the further development of the company, we support the Regulatory Affairs department in recruiting a Regulatory Support Expert (m/f/d) at the Hamburg location

Your tasks:

• Creation of technical files to maintain the regulatory status after updating the technical file (IVDR)
• Point of contact for submission and queries related to technical files and on-site clinical datasets
• Creation of regulatory strategies and evaluation of projects
• Product classifications and product registrations (MDSAP and other countries)
• Carrying out regulatory and clinical tasks according to the quality management manual
• Implementation of legal texts and/or product standards
• Interface and active communication to all departments
• Approval of IFUs / Marketing Material / Label

Your profile:

• Successfully completed studies in the field of medicine, biotechnology, pharmacy or Chemistry
• At least 3 years of relevant professional experience in in-vitro diagnostics or in the field of medical devices in a comparable position with regulatory tasks
• Language skills: German and English (business fluent, spoken and written) solid knowledge of MS Office, Outlook, Adobe,
• Expertise in GMP, Regulation 2017/746, Directive 98/79/EC / ISO 13485:2016 high quality awareness

You can expect an exciting, dynamic environment with a high degree of personal responsibility and initiative. You will work in a committed team with extensive social benefits in an international company.

If you feel addressed, we look forward to hearing from you