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Regulatory Compliance Officer

Job Posted: 5 days ago

Salary: £ Competitive
Job Type: Permanent
Location: Gateshead, Tyne & Wear

Expire in: 23 days

Job Description

Jackson Hogg are proud to be exclusively supporting a specialist manufacturing business in the Gateshead area on a Regulatory Compliance Officer position.

Regulatory Compliance Officer Responsibilities

  * Monitor, interpret, and disseminate information on new and changing regulations, including but not limited to:

  * Pharmaceutical and Biocompatibility Standards: USP <87> and <88>, ICH Q3C (Residual Solvents), ICH Q3D (Elemental Impurities), and USP <383>/EP 3.1.5 for closures.

  * 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

  * Approve or reject validation and qualification documentation, including sterility validation per ISO 11137.

  * Initiate and manage CAPAs related to regulatory non-compliance, including sterility or chemical safety failures.

  * Make recommendations on supplier and vendor selection based on regulatory compliance (e.g., REACH, RoHS, Prop 65).

  * Stop processes or activities that are deemed to be non-compliant with regulations (including sterility processes), pending review with the Quality Manager and Division Management Team.

Regulatory Compliance Officer Requirements

  * Engineering knowledge is not essential; however, demonstrable chemistry knowledge or qualification is critical due to the technical nature of substance assessments, chemical legislation, and required testing protocols.

  * 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

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