Our client is a consulting company that is focused in the medical device industry. They provide consulting services for product development, with a heavy emphasis on pre-market work.
This position is a full time, salaried role with full corporate benefits and offers a fast-growth career opportunity that you will rarely see in the industry.
This is a small team of tenured Engineers and Regulatory Affairs SMEs, who will able to train and help someone develop in all areas of Quality and/or Regulatory Affairs. You will work hand in hand with clients and consulting services team members. This is an environment that fosters professional development, engineering excellence and a creative approach to the industry’s toughest product design challenges.
Are you an early career Engineer, looking to gain breadth of skills and knowledge, working with a variety of technologies without having to change jobs?
Do you enjoy a small, family-like environment where people help each other be their best? (and offers a chance to work remotely)?
If so, this is the opportunity for you! Apply now to learn more about how you can catapult your career in the industry!
• 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
• Assist with regulatory pathways and strategies, premarket FDA, and international regulatory submissions
• 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
• 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
• FDA Regulatory submission experience (Pre-Submission, 510ks, PMAs, IDEs) is a plus.