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, dose mapping, routine monitoring, documentation, and audit readiness for sterility claims.
* Conduct internal audits and gap analyses to assess compliance with applicable regulations.
* Oversee the CAPA system for regulatory-related findings.
* Manage supplier and vendor regulatory qualification and maintain quality agreements, ensuring compliance with REACH, RoHS, Food Contact, and other relevant standards.
* Support regulatory submissions and notifications related to sterility (ISO 11137), biocompatibility, food contact, and chemical compliance.
* Review and approve validation and qualification documentation for systems and equipment, including critical documentation for gamma irradiation processes and dose audits per ISO 11137.
* Deliver training on regulatory requirements to all relevant personnel, including ISO 11137, biocompatibility, and chemical compliance topics.
* Act as the primary point of contact for regulatory agency inspections and customer audits concerning sterility, biocompatibility, food contact, and chemical regulations.
* Maintain all regulatory documentation and evidence of compliance for the listed regulations and the ISO 11137 program.
* Coordinate incident and recall activities as required, particularly those triggered by non-compliance with sterility or chemical safety standards.
Regulatory Compliance Officer Requirements
* Experience in a regulatory or quality role within the pharmaceutical, medical device, or life sciences industry.
* In-depth knowledge of key regulations such as ISO 9001, ISO 13485, FDA 21 CFR Part 820, EU GMP, and ISO 11137.
* Experience in hosting or participating in regulatory inspections and customer audits.
* Strong understanding of data integrity principles (ALCOA+).
* Excellent communication and interpersonal skills.
* Proven ability to manage multiple projects and priorities.
* Strong analytical and problem-solving skills.
* Regulatory Knowledge
* Deep understanding of the regulatory landscape — including sterility (ISO 11137), biocompatibility, food contact, and chemical regulations — and the ability to apply it to specific products and processes