Regulatory Affairs Specialist

Applied Medical Technology, Inc.; Brecksville (OH); On-site; USD 65,000 - 95,000; Full time

Job summary

Applied Medical Technology, Inc. in Ohio seeks a Regulatory Affairs Specialist to manage submissions to regulatory agencies and ensure ongoing compliance for domestic and international markets.

You will collaborate with the Regulatory team and various departments to prepare FDA 510(k) submissions, EU Technical Files, and maintain up-to-date documentation.

The role requires attention to detail, strong communication, and knowledge of ISO 13485 and GMP requirements.

Qualifications

• Minimum of 2-year college degree required; Bachelor’s preferred.
• Experience in medical or regulated industry is desirable.
• Knowledge of ISO 13485 and FDA regulations is desirable.
• Experience creating and revising labels and DFUs preferred.

Responsibilities

• Prepare and submit regulatory documentation to FDA, Notified Bodies, and other regulatory authorities.
• Prepare and maintain European Technical Files for MDR/IVDD compliance.
• Create and modify regulatory procedures to stay compliant with FDA, ISO, European and Canadian standards.
• Coordinate regulatory filings for product registrations with international teams.
• Provide regulatory support for other projects and update personnel on changes.

Skills

Communication across functions

Microsoft Office

Prioritization and independence

Education

2-year college degree

Bachelor’s degree or higher preferred

Tools

Microsoft Office Suite

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.