Quality & Regulatory Engineer

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

• Base Pay $80,000.00 - $95,000.00 / Year
• Job Category Quality Systems Engineer, Regulatory Affairs Engineer
• Industry Medical Device, Regulatory Affairs
• Employee Type Full Time Exempt
• Required Degree 4 Year Degree
• Manage Others No

Contact information

Description

• 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
• Assists in communication with regulatory agencies via pre-submissions and responses to premarket submission requests
• Development, revision and/or ongoing operation of Quality System procedures and processes
• Internal and supplier audit planning and execution
• Serve as a company representative during external audits by Regulatory and Third Party Auditors
• Design Control documentation assistance
• Validation and Testing Protocol support
• Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements

Requirements

• 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-Submission, 510ks, PMAs, IDEs)
• Quality Systems development, implementation, and training experience
• Direct experience working on processes within a Quality System (ex. CAPAs, complaint management, document controls, supplier controls)
• Experience with ISO 13485 and FDA compliance requirements and training
• Experience with Risk Management per ISO 14971
• Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls a plus
• Candidate must be a self-starter, self-motivated, and results oriented
• Excellent interpersonal and written communication skills with high attention to detail in written work
• Must be able to work independently and have ability to work with cross-functional internal and external teams
• Strong time-management skills with the ability to work under tight timelines and able to multi-task
• Interest in taking on new challenges and expanding quality/regulatory skillset through on-the-job training and experience

Summary

We are currently seeking a self-motivated, charismatic individual to join our regulatory and quality engineering team. A successful candidate for this position possesses exceptional technical skills and understanding related to working in the highly regulated medical device industry. This individual will have direct support from leadership and team members through training and continuous learning. We offer a very competitive salary, commensurate with the role and your experience as well as an attractive, comprehensive benefits package. If you ’re looking for an autonomous career opportunity while working in a transparent and positive culture that promotes professional growth and teamwork, this is your opportunity!

Why JALEX Medical:

• Benefits: Medical, Dental, Vision, Life Insurance, 401(k) match, generous PTO and 12 Paid Holidays, Wellness Program with Fitness Center and Training Classes, Flexible Schedule including remote work from home days
• Company Cell phone and Laptop
• Training and Support in Developing your Understanding of Medical Device Development, Regulatory Affairs, and Quality Management Systems
• Exciting, Fast-Paced, and Team-Oriented Culture with Fun Company Outings and Team Building Activities
• Great Opportunity to get in on a Growing, Enthusiastic Company and Establish Yourself as a Long-Term Key Member

Why You’ll Love It Here

This isn’t just a job, it’s your chance to build a career in MedTech where your work contributes to improving patient lives. You’ll join a team that’s both serious about quality and compliance and knows how to celebrate wins along the way. If you want to expand your skills, work with global clients, and be part of an energetic company that’s scaling fast, we’d love to meet you!