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Regulatory compliance officer

Gateshead
Permanent
Jackson Hogg Ltd
Regulatory compliance officer
Posted: 22h ago
Offer description

Jackson Hogg have proudly partnered with an industry leading manufacturing business on a brand new role due to business expansion and growth. The Regulatory Compliance Officer will play a key part in the business to support new product launches and oversee Product and Materials Compliance. Regulatory Compliance Officer Responsibilities * Monitor, interpret, and disseminate information on new and changing regulations, including but not limited to: * Food Contact Regulations: EU 1935/2004, EU 10/2011, FDA 21 CFR 177.1550 & 21 CFR 177.2600, BfR XV, California Proposition 65, and Japanese Food Utensils regulations * Pharmaceutical and Biocompatibility Standards: USP and, ICH Q3C (Residual Solvents), ICH Q3D (Elemental Impurities), and USP /EP 3.1.5 for closures, ensuring compliance for applicable products like Sensors and Manifolds * Environmental and Chemical Regulations: RoHS, REACH (including Substances of Very High Concern like Bisphenol A, Phthalates, PAHs, etc.), EU Deforestation Regulation (EUDR), PFAS regulations (EU and Canada), and regulations concerning CMR (Carcinogenic, Mutagenic, Reprotoxic) and PBT (Persistent, Bioaccumulative, Toxic) substances across relevant product lines. * General Safety: BSE/TSE guidelines (EMA 410/01). * Manage the company’s gamma irradiation and sterility assurance program in full compliance with ISO 11137. This includes overseeing validation,...

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