Regulatory Affairs Specialist (m/f/d)
Core
Ensure new products meet global regulatory requirements and facilitate their integration into the distribution portfolio.
Role type
Regulatory Affairs Specialist
Builds
Distribution portfolio of medical devices, biotechnology, biopharmaceuticals, and chemical products
Domain
Life Sciences / Regulatory Compliance
Required skills
Regulatory compliance evaluation, Risk assessment, Supplier evaluation, Technical writing, Documentation management, Regulatory landscape monitoring, Cross-functional collaboration, Project management
Preferred skills
Quality Management knowledge, Regulatory submission experience, Regulatory database proficiency
Technologies
Microsoft Office (Word, Excel, PowerPoint), Regulatory databases
Responsibilities
Maintain processes for new item creation, Collaborate with business development on portfolio expansion, Work with suppliers to verify compliance, Monitor regulatory changes, Conduct risk assessments for new products, Collaborate with cross-functional teams