We are recruiting a self-motivated, charismatic individual to join our client’s 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. They 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!
This company provides training and support in developing your understanding of medical device development, regulatory affairs, and quality management systems. This is an exciting, fast-paced, and team-oriented culture with fun company outings and team building activities. And also, there is a great opportunity to get in on a growing, enthusiastic company and establish yourself with a well-established and high functioning team.
This position involves all aspects of Regulatory and Quality, including customer consultation, marketing support, design and development support, and post launch surveillance for customers.
*This can be a remote based position, but onsite meetings with a team in Cleveland are required.
• Assist with devising and executing regulatory pathways and strategies, premarket FDA, and international regulatory submissions.
• Assist with development and/or revision of Quality System procedures and processes.
• Assist with 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.
• Bachelor’s Degree in Engineering, Science, or health-related field
• 2+ years’ of Regulatory Affairs 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
• 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
• Must be able to work independently and have ability to work with cross-functional teams
• Project management skills with the ability to work under tight timelines and able to multi-task