- 01295 266288
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Our prestigious partner is an industry-leading global player, developing and manufacturing pioneering medical products under their own brand as well as providing custom device solutions for the world’s leading pharmaceutical and diagnostic companies.
The Regulatory Affairs & Design Controls Officer is responsible for the development and implementation strategies that will ensure the timely introduction of products into the international market in conjunction with project teams. You will Identify applicable regulatory requirements to progress projects/products, advise and support internal and external customers on these requirements and are responsible for verifying compliance to quality and regulatory requirements for device development.
Duties include (but not limited to)
- Arrange and manage licences for the assembly of drug products (combination drug delivery products) meeting requirements of international Competent Authorities (primarily but not limited to MHRA, FDA) and the requirements of the Home Office
- Develop and implement strategies that will ensure the timely introduction of products into the international market in conjunction with project teams
- Identify applicable regulatory requirements to progress projects/products and advise and support internal and external customers on these requirements and opportunities.
- Represent the regulatory team as the main point of contact with project teams and the customer on specified projects
- Responsible for verifying compliance to quality and regulatory requirements for device development and design control.
- Responsible for providing quality and compliance guidance to associates in Research & Development
- Support Associates at all levels of the business to assure required documentation is completed in sequence and in a timely manner and to support continued business compliance and success
- Responsible for all quality aspects for development projects and design control with key customer(s)
- Develop and coordinate a program to ensure all international registrations and licences are completed efficiently and to an agreed timeline.
- Manage the creation and development of Technical Files for products/project in compliance with the Medical Devices Directive.
- Responsible for advising/supporting OEM customers and internal SMEs to assure the continued Regulatory Compliance of existing products throughout their life cycle
- Review proposed marketing materials, packaging, Instructions For Use and Label copy for Regulatory compliance to Annex I for CE marked devices and to the appropriate requirements for ROW markets
- Manage a program to ensure efficient scheduling of licence maintenance and renewals and support Competent Authority audits to the licences.
- Drive of company associates to prepare and collate required documentation to support submissions for product approval and maintenance (e.g. Variations to Marketing Authorisations, FDA 510K), NDA/BLA etc)
- Assure continued compliance with regulatory requirements to maintain applicable certifications and GMP/Manufacturing Licences to support Business Strategy
- Responsible for supporting the timely registration of all current and new products with the correct regulatory authorities
- Maintain a knowledge of current and pending relevant regulations and guidance documents and communicate these to the business
- Identify all applicable key regulatory requirements and opportunities that relate to a product/project to support the development and ultimate successful launch of new products and into new markets
- Manage the creation and development of the portfolio of Technical Files and licences
- Work with customers and internal SMEs to assure the continued Regulatory Compliance of existing products throughout their life cycle
- Review and approve all device development documents (e.g. design input requirements, design reviews, design verification test protocols, design verification test reports etc.) for both new devices undergoing development and for existing devices undergoing continuous improvement
- Responsible with support of Quality Management to take projects forward through R&D into industrialisation
- Approve all R&D documentation for Quality (including R&D events)
- Interface with customers to understand their requirements and present company processes and documentation to them with confidence and assertiveness
- Support SME’s in areas of responsibility in maintaining Standard Operating Procedures and related documents, reviewing regulatory and industry trends as well as customer requirements and internal exceptions raised and audit observations to implement Continuous Improvement
- Interface with auditors (external and internal) to confidently present processes and records to demonstrate quality compliance
- Work with managers and SME’s to assist investigation and close out of any related Corrective and Preventive Actions (CAPAs) arising from either internal or external audits in area of responsibility
- Report to Quality Management on progress with activities, provision of metrics and other information (e.g. input to Monthly Business Reports, Quarterly Reports) to identify trends/ areas of opportunity for improvement and escalation of issues
- Establish and maintain familiarity with current Best Practice in quality compliance aspects of device development and design control
- Any other activity as directed by the Regulatory Affairs Manager or Head of Quality
You will be have
- Experience of drug device combination regulatory strategies and submissions in the US and EU medicinal product manufacture and handling licensing
- Experience of controlled drug/cold chain licensing
- Experience in drug submission creation or drug submission support
- Medical Devices Directive (93/42/EEC) and /or the IVD Directive (98/79/EC)
- Experience in regulatory submissions for medical devices and/or in vitro diagnostic devices (working with Class I, II or III Devices).
- ISO 13485 lead auditor and ISO 14971 (both preferable)
- Excellent written and oral skills
- Excellent interpersonal skills with an ability to work on their own initiative and as part of a multi disciplinary
What’s on offer?
- A competitive salary – call me for details.
- Access to company benefits scheme after 3 months’ service.
If you have read this job description and would like to apply, please send an up to date CV to email@example.com. For more information, please call 01295 266288 and speak to Matt. I look forward to hearing from you!