Quality & Regulatory Engineer

• 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

• 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

• 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

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!

• 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 Med Tech 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!