Regulatory Affairs
1 month ago
Regulatory Affairs and Quality Manager
Coventry, CV3 2RQ Salary: Competitive, DOE Contract: Full time, Permanent
Regulatory Affairs and Quality Manager - Benefits:
Competitive salary
Contributory pension scheme
Life cover
Cash Back Medical Scheme
We are an innovative medical devices manufacturer of advanced wound care products, including combination products, from gelling fibres and fabrics. We deliver innovative, cost effective and quality products and solutions for the advanced wound care industry helping to improve patient care and wellbeing.
Regulatory Affairs and Quality Manager - The Role
This role is responsible for the delivery of the company’s development regulatory roadmap. This will be achieved through leading the regulatory elements of the company’s product development efforts and compliance programme as well as supporting its customers’ regulatory requirements and
projects.
Lead the provision and development of regulatory strategies, participate in project teams and act as the lead person with regards to regulatory requirements for product development and design changes.
Deliver regulatory and compliance inputs into product development and regulatory projects, including coordination of RAQ function resources for development and design change control projects.
Undertake the role of the Regulatory Project Lead (RPL) in business projects supporting the delivery of relevant outputs from the project and managing the regulatory project, with clear leadership.
Support the development of global regulatory strategies for the company and its customers’ development for new and modified products for primary markets USA, EU, and UK.
Maintain compliance and improvement to the business compliance and regulatory systems including the risk management programmes.
Assess the impact of global regulatory and standard changes on the products and Quality Management System (QMS) of the business and its customers, acting as the Subject Matter Expert (SME) and maintaining the business’ regulatory database.
Lead the delivery of the company’s quality and regulatory training and awareness program to provide the company with enhanced knowledge of regulatory requirements.
Support the management of communication with Regulatory Authorities and Notified Bodies to address regulatory and compliance issues.
Support the delivery of the regulatory requirements of the QMS including managing CAPAs, document change controls, audits.
Contribute to create and maintain a proactive leadership style and compliance culture throughout the company to achieve high standards of excellence, sharing best practice.
Regulatory Affairs and Quality Manager - Key Skills / Abilities:
Regulatory, science or engineering degree or equivalent.
Knowledge of the Medical Device Directives Regulation EU 2017/745/EEC, 21 CFR 820, UKCA
Ability to gather, analyse and interpret regulatory information and changes in the regulatory landscape, taking ownership for delivery.
Networking abilities with internal and external stakeholders (competent authorities and registration bodies).
Comprehensive knowledge of processes and regulations in medical device and drug development; Medical device or pharmaceutical product manufacturer experience.
Experience of developing regulatory strategies for new product development and design changes.
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