Role:

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, we’d love to hear from you!

Essential Responsibilities:

· Identifies regulatory classification and designation per relevant regulations, guidance documents, international standards, or consensus standards

· Prepares premarket FDA, and international regulatory submissions, with technical review of data and reports

· Communicates with regulatory agencies via pre-submissions and responses to premarket submission requests

· Development and/or revision of Quality System procedures and processes

· Internal and supplier audit development, implementation, and execution

· Serve as a company representative during external audits by Regulatory and Third-Party Auditors

· Design Control documentation assistance

· Validation and Testing Protocol Development

· Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements

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-Submission, 510ks, PMAs, IDEs)

· International submission experience a plus

· 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, FDA, MDR (Medical Device Regulation), and CMDR (Canadian Medical Devices Regulations) compliance requirements and training

· Experience with Risk Management per ISO 14971

· Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls

· 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

· Extensive project 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

This position involves all aspects of Regulatory and Quality, including customer consultation, marketing support, design and development support, and post launch surveillance for our customers.

JALEX Medical, LLC

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Regulatory/Quality Systems Engineer