What are the responsibilities and job description for the Medical Device Compliance Expert position at JALEX Medical, LLC?
About JALEX Medical, LLC
We are a leading provider of innovative medical devices, committed to delivering high-quality products that meet the needs of our customers. Our team is comprised of experienced professionals who share a passion for excellence and a commitment to customer satisfaction.
Job Overview
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.
Key Responsibilities:
• Identifying regulatory classification and designation per relevant regulations, guidance documents, international standards, or consensus standards.
• Preparing premarket FDA and international regulatory submissions with technical review of data and reports.
• Communicating with regulatory agencies via pre-submissions and responses to premarket submission requests.
Required Skills and 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.
Benefits:
We offer a very competitive salary commensurate with the role and your experience, along with an attractive comprehensive benefits package.
