Regulatory Affairs Specialist (Brecksville, OH

Regulatory Affairs Specialist (Brecksville, OH)

This position is responsible for preparing submissions to various regulatory agencies and maintaining compliance. Candidate must work well in a team and have great attention to detail.

• Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA, Notified Bodies, and Authorized Representatives.
• Prepare, maintain, and submit, when necessary, European Medical Device Directive and European Medical Device Regulation compliant Technical Files.
• Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.
• Work with the international department on various regulatory filings for product registration in different countries.
• Provides regulatory support for other projects as required.
• Updating appropriate personnel on new and revised processes and procedures.
• Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems.
• Preparing change order documentation and routing it for final approval.

None

• Minimum of 2 year college degree, Bachelor’s Degree (or greater) preferred.
• Relevant work experience, preferably in the medical or legal field and/or other regulated industry.
• Previous experience creating and revising labels and DFUs preferred.
• Knowledge of European, ISO 13485 and FDA regulations preferred.
• Knowledge of international regulatory guidelines regarding GMP requirements is desirable.

Ability to communicate across functions, professional levels and background.

Intermediate to advanced knowledge of Microsoft Office Suite.

Mental:
Must be able to effectively communicate with others; complete and understand complex situations, analysis of numbers; read, analyze and interpret written materials; work with team to meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems.

Physical:
Must be able to communicate for hours at a time, use computer equipment. Moderate noise level and limited exposure to physical risk.

Knowledge of modern business communication, office procedures and methods. Skill to use a personal computer and various software packages such as Microsoft Office Suite. Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.

Telephones, computer, other office equipment as needed.

Persons in this position may be required to pass a drug, alcohol, and/or criminal background check.