Advanced Regulatory Affairs Specialist

Role Summary

Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files.

Responsibilities

• Works in the regulatory affairs department on assigned projects.
• Maintain regulatory files.
• Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.
• Collaborates with key staff from Planning, Product Development, Operations, and Legal departments as required.
• Review and approve documents, labels, and other documentation.
• Assist with design control activities.
• Assist in Risk Management activities.
• Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance with the job.
• Perform additional duties as assigned.

Education

• A Bachelor’s degree with 2-4 years of relevant experience.
• Or, a Master’s degree with up to 3 years of relevant experience

Knowledge, Skills, And Abilities

• Attention to detail and organizational skills are required
• Working knowledge of Microsoft Word and Excel are required
• Computer entry, typing, or electronic document filing skills are required.
• Must be able to work in a fast-faced environment where multitasking is required
• Must have excellent verbal and written communication skills
• Knowledge of technical, regulatory, quality and production management systems
• Knowledge of documentation principles and processes
• Skills in accuracy, clarity and proofreading
• Skills in problem solving, identifying root cause and appropriately evaluating a course of actions
• Knowledge of global regulations associated with in-vitro diagnostics
• Technical document writing skills