Regulatory Affairs Specialist - Birmingham
Regulatory Affairs Specialist
Duties and Responsibilities:
- Extensive knowledge of the Company's products, policies and procedures.
- Knowledge of FDA 21 CFR 820 - 510k process, IVDD - CE marking and ROW regulations/registration processes.
- Knowledge of the Company's products clinical use and the environment they are used in.
- Knowledge of internal procedures, processes and document stores.
- Able to analyze and interpret complex data.
- Can offer general advice on regulatory strategy for new products and product changes
- Can complete a 510k submission with minimal supervision.
- Can undertake CE marking activities and has a good understanding of the requirements of the IVD directive.
- Able to recognize post market surveillance issues that require corrective action and reporting.
- Can liaise directly with international regulatory agencies and provide supporting documentation, handle queries and issues
- To contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality System.
- To update on the progress of registration processes and other RA group activities to line management when requested.
- To be responsible for planning own workload and works with limited input from the line manager, influencing personal training and assisting in setting appropriate time lines for projects.
- To assist with the regulatory compliance of marketing communications/messages for the Company's products and services.
- Ability to listen and quickly understand
- To be able to communicate clearly and effectively with people at all levels.
- To discuss technical/regulatory issues with other departments as required.
- To communicate work on a daily/weekly basis to manager/supervisor
- To be able to challenge opinions based on specialist knowledge which will involve discussing complex and confidential information.
- To disseminate knowledge gained during private study and training, to contribute to the knowledge of colleagues
- To maintain oneself in a professional manner towards colleagues, external contacts and promoting the company in a positive manner at all times.
- Uphold the ethical principles of Regulatory affairs and flag any issues that are inconsistent with the Company's quality policies and good manufacturing practice.
- Strive to understand, facilitate and assist in situations where regulatory support is required, act with urgency to ensure that resolutions are achieved.
- Strive to keep abreast of new regulatory requirements/updates and bring best practices to the Company.
- It should be noted that the work of the Company is of a confidential nature and must not be communicated to other persons except where required for authorized purposes.
Knowledge and Skills
- A scientific, medical or engineering background - preferably with a degree or equivalent and/or proven regulatory experience.
- Knowledge of the clinical laboratory environment or the IVD industry.
- General regulatory affairs, understanding of CFR's, IVDD etc.
- Demonstrable ability in technical reasoning and problem solving.
- IT literate - Microsoft office expertise
- Team player
- Reliable and flexible
- Excellent work ethic
- Experience in Biology, healthcare or related disciplines
- Understanding of Statistics
- Understanding of CLSI guidelines
- Project management skills
- Foreign language
To apply, please click on the 'Apply' button.