Regulatory & Quality Engineer - Remote-Friendly Growth

GOEBEL FIXTURE COMPANY; Westlake (OH); Hybrid; USD 80,000 - 95,000; Full time

Benefits offered by this job

Benefits package including medical, 12

401(k)

Paid holidays

Job summary

JALEX Medical is seeking a self-motivated Regulatory and Quality Engineer to join our highly regulated medical device team in the United States. You will support regulatory classification, design control, and Quality System processes while collaborating with cross-functional teams to ensure compliance.

The role requires a Bachelor’s degree and 2+ years in medical devices, with hands-on experience in FDA submissions, ISO 13485, and ISO 14971 risk management.

Qualifications

• Bachelor's degree in Engineering, Science, or health-related field.
• 2+ years’ related work experience in the medical device industry.
• Working knowledge of FDA and other regulatory authorities.
• FDA Regulatory submission experience (Pre-Submissions, 510k, PMAs, IDEs).
• Quality Systems development, implementation, and training experience.
• Direct experience with Quality System processes (CAPAs, complaint management, document controls, supplier controls).
• Experience with ISO 13485 and FDA compliance requirements and training.
• Experience with Risk Management per ISO 14971.

Responsibilities

• Identifies regulatory classification and designation per relevant regulations, guidance documents, international standards, or consensus standards.
• Assists in preparation of premarket FDA and international regulatory submissions, with technical review of data and reports.
• Communicates with regulatory agencies via pre-submissions and responses to submission requests.
• Develops, revises, and operates Quality System procedures and processes.
• Plans and executes internal and supplier audits.
• Represents the company during external audits by Regulatory and Third Party Auditors.
• Assists with Design Control documentation.
• Supports Validation and Testing Protocols.
• Performs gap assessments against new and revised Quality Modules, Directives, and ISO requirements.

Skills

Regulatory knowledge

FDA experience

Quality Systems

Cross-functional teamwork

Education

Bachelor's degree

Job description

JALEX Medical is seeking a self-motivated Regulatory and Quality Engineer to join our highly regulated medical device team in the United States. You will support regulatory classification, design control, and Quality System processes while collaborating with cross-functional teams to ensure compliance.

The role requires a Bachelor’s degree and 2+ years in medical devices, with hands-on experience in FDA submissions, ISO 13485, and ISO 14971 risk management.