Description
Role and Responsibilities:- Provide direction to Research & Development (R&D), New Product Development (NPD), and Marketing on UK/EU requirements to be incorporated in the development of products. Provide long term solution options to effectuate timely design inputs into the development process. Provide label and promotional material review and sign off consistent with UK/EU requirements for medical device and pharma products.
- Execute the assembly of common technical documents/ product information packages that support the registration ofUK(and US imported) developed products. Provide long term solution options to aid in the automated assembly of such information.
- Facilitate timely resolution of product regulatory issues through relevant C&D groups, subsidiaries, and/or local market experts. This includes the review and reporting of adverse events, CAPA, and field notices/recalls.
- Corporate representative on all notified body and competent authority audits of C&D UK facilities.
- In partnership with subsidiaries or local market experts, evaluate new local and international regulatory issues/requirements and communicate impact to relevant groups within C&D. Provide solution options to address new regulatory issues.
- Develop network of local market experts to advise regulatory execution for new product categories or markets
Skills and Competencies:
- Demonstrated leadership skills with strong results orientation
- Broad knowledge and acute understanding of regulations/directives for medical devices (93/42/EEC as amended and 98/79/EEC), general sale pharmaceuticals /EEC as amended), cosmetics (Regulation ) and voluntary standards .
- Broad knowledge and acute understanding of Quality Management Systems as outlined in ISO 9001 & ISO 13485 for medical devices.
- Demonstrated ability to exercise sound judgment, manage multiple projects, work cross-functionally, and deliver against company business goals and objectives.
- Ability to supervise 2 individuals.
- Excellent HR and communication skills, presentation skills.
To find out more about Real please visit www.realstaffing.com