Regulatory Affairs Specialist (Brecksville, OH)

Cedent; Brecksville (OH); In loco; USD 65.000 - 85.000; Tempo pieno

Descrizione del lavoro

A leading healthcare company is seeking a Regulatory Affairs Specialist in Brecksville, OH, responsible for preparing and submitting regulatory documentation to various agencies, maintaining compliance with FDA and international regulations. The ideal candidate will possess a minimum of a 2-year college degree, relevant experience, and advanced knowledge of Microsoft Office Suite. Attention to detail and strong communication skills are essential for this role, ensuring the company meets standards and regulations.

Competenze

• Minimum of 2 year college degree; Bachelor's preferred.
• Relevant work experience in medical or legal fields.
• Knowledge of FDA and international regulatory guidelines.

Mansioni

• Prepare and submit regulatory documentation to agencies.
• Maintain compliance with FDA and international standards.
• Work with international department for product registration.

Conoscenze

Communication skills

Knowledge of FDA regulations

Knowledge of European regulations

Teamwork

Attention to detail

Formazione

Minimum of 2 year college degree

Bachelor’s Degree (or greater) preferred

Strumenti

Microsoft Office Suite

Descrizione del lavoro

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.

Duties and Responsibilities

• 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.

Supervisory Responsibilities

None

Minimum Qualifications

Education and/or Experience

• 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.

Language/Communication Skills

Ability to communicate across functions, professional levels and background.

Computer Skills

Intermediate to advanced knowledge of Microsoft Office Suite.

Essential Job Functions

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, Skills, and Abilities Required

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.

Equipment Used

Telephones, computer, other office equipment as needed.

Special/Additional Requirements

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