The Regulatory Specialist is a key member of the Compliance Team, responsible for supporting and maintaining regulatory compliance across the business. The role focuses on ensuring that products, processes and quality systems meet applicable UK, Swiss, EU and international regulatory requirements.
Working closely with internal stakeholders and regulatory authorities, the Regulatory Specialist provides regulatory expertise across product registrations, vigilance, regulatory intelligence, change assessments and technical documentation.
Key Responsibilities
* Manage regulatory activities
* Oversee regulatory compliance activities including vigilance, regulatory intelligence, change assessments and regulatory submissions.
* Act as a key point of contact with regulatory authorities, including the MHRA and Swissmedic.
* Manage product inclusion activities for the UK and Swiss markets, ensuring products meet relevant regulatory requirements.
* Assess changes to regulatory requirements, legislation and quality standards and determine their impact on the Quality Management System.
* Support the implementation of regulatory and quality requirements across the organisation.
* Manage and maintain technical documentation
* Provide clear regulatory advice and communicate effectively with internal stakeholders, including executive-level leadership.
* Support the ongoing development and maintenance of quality and compliance systems.
* Identify opportunities to improve regulatory processes, communication and productivity.
* Maintain awareness of relevant company policies, regulatory requirements and industry best practice.
* Support other compliance and regulatory activities as required by the Compliance Manager.
Experience & Qualifications
* Degree or equivalent qualification, preferably within a life sciences discipline.
* Relevant experience within the life sciences, medical device or similarly regulated industry.
* Experience within the In-Vitro Diagnostics (IVD) sector would be advantageous.
* Strong knowledge of Quality Systems, Quality Assurance and regulatory compliance.
* Knowledge of relevant standards and regulations, including ISO 13485, 21 CFR, MDSAP, EU IVDD/IVDR and ISO 14971.
* Experience working with Electronic Document Management Systems (EDMS).
* Proficiency in Microsoft Word, Excel and PowerPoint.
Skills & Competencies
* Strong attention to detail with a high level of accuracy.
* Excellent organisational and time-management skills.
* Strong written and verbal communication skills.
* Confident communicating with senior and executive-level stakeholders.
* Ability to interpret regulatory requirements and assess their impact on business and quality systems.
* Self-motivated, proactive and committed to continuous professional development.
* Able to work effectively both independently and as part of a small, collaborative team
Salary description
£23.08 - £23.08 per hour