Regulatory Affairs Specialist

RXinsider LTD.; Brecksville (OH); On-site; USD 70,000 - 110,000; Full time

Job summary

RXinsider LTD. seeks a Regulatory Affairs Specialist to prepare submissions to FDA and international regulators, and to maintain compliance across domestic and global markets. The role emphasizes strong teamwork and meticulous attention to detail.

The candidate will manage regulatory documentation, collaborate with the international department on registrations, and ensure procedures meet ISO 13485 and FDA standards. Experience preferred in medical or regulated industries.

Qualifications

• Ability to communicate across functions and professional levels.
• Excellent attention to detail and accuracy in submissions.
• Strong teamwork and collaboration in a regulatory environment.

Responsibilities

• Prepare and submit regulatory documentation to FDA, Notified Bodies, and Authorized Representatives.
• Prepare and maintain regulatory Technical Files for EU MDR/IVD and FDA compliance.
• Create and update regulatory procedures to meet FDA, ISO, and international standards.
• Coordinate with international regulatory filings for product registrations in multiple countries.
• Provide regulatory support for cross-functional projects as needed.
• Update personnel on new regulatory processes and changes to procedures.
• Organize and archive internal documentation related to Engineering and Quality Systems.
• Prepare change orders and route for approvals.

Skills

Team collaboration

Attention to detail

Communication across functions

Problem solving

Education

Bachelor’s degree or higher

Minimum 2-year college degree

Tools

Microsoft Office

Job description

Description:

Job Title: Regulatory Affairs Specialist

Department: Regulatory

Reports To: Director of Regulatory Affairs

FLSA Status: Exempt

Supervise the work of others: No

Position Summary:

This position is responsible for preparing submissions to various regulatory agencies. Additionally, the position will help maintain and improve upon domestic and international compliance. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail.

Duties And Responsibilities:

This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties may be assigned.

• 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:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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

Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.

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.

Requirements:

Minimum Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.