Regulatory Affairs Specialist
- Ownership of Regulatory Strategy, and Audit Programs
- Global leader, North West based
- Competitive salary package, immediate growth opportunities
Global supplier within the drug delivery arena. Strong presence in the UK and across Europe, offering 50 years of expertise to both the pharmaceutical and medical device industries. Reporting to the Global Director of QA/RA, you will have the autonomy to build and sustain processes.
About the Opportunity
- Ownership and delivery of the Regulatory Affairs requirements, including submissions and post market surveillance
- Management of ISO 13485 Compliance, Development, Implementation and Training of all related and supporting processes
- Auditing all aspects of ISO 13485 and ISO 15378 within the organization and associated supply chain partners where appropriate.
- Training in the field of GMP, GCLP, Regulatory Affairs and CAPA.
- Supporting development activities to ensure early implementation of the legal requirements
- Collaboration with co-workers regarding Regulatory Affairs ensure efficiency with other business areas to minimize duplication of effort
- Maintenance of Drug Master Files (DMF), Annual reports and updates as appropriate in addition to all Product Approvals and CE Declarations.
- To maintain an independent perspective on Product Approval and Manufacturing Production Processes and Product Performance
- To ensure the monitoring and reporting of Product Performance and Post Sales Management
- Regulatory management of customer complaints and Corrective and Preventive Action Management
Skills and Experience
- Prior experience in a highly regulated market within the healthcare arena
- Strong kknowledge of EU/2017/745, 90/385/EEC, 93/42/EEC, 89/79/EC.
- Knowledge of ISO 13485 and ISO 15378, UK Legislation and UKCA Marking Requirements.
- Experience delivering on business management, change management and improvement
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.
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