Regulatory Affairs Specialist - Birmingham

Recruiter
Harrington Recruitment
Location
Birmingham
Salary
30000.00 GBP Annual
Posted
03 Jul 2017
Expires
28 Jul 2017
Contract Type
Permanent
Hours
Full Time

Regulatory Affairs Specialist
Location:
Birmingham
Salary: GBP30,000

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.

Communication:

  • 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

Professionalism

  • 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

Essential:

  • 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.
  • GMPs/ISO13485
  • 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
  • Self-motivated
  • Positive
  • Excellent work ethic

Desirable:

  • 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.