Our client is looking for a Regulatory Affairs Specialist with experience of Medical Devices and Diagnostics.
Bachelor's degree with at least 3 years of regulatory work experience, science degree preferred or equivalent level of education and work experience.
Excellent analytical and communication skills, particularly writing skills, are essential.
Demonstrated computer literacy is required.
Ability to travel a minimum of 20% both domestically and internationally is required.
KNOWLEDGE, SKILLS AND ABILITIES:
• Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international. as it pertains to Medical Device studies.
• Experience interacting with regulatory agencies is preferred.
• Ability to understand and communicate regulatory requirements for different therapeutic areas and countries and associated submission pathways.
• Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
• Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
• Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
• Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
• Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
• Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
• Ability to read and synthesize technical material and to prepare clear and concise written documents.
• Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.