What are the responsibilities and job description for the Medical Device Compliance Specialist position at JALEX Medical, LLC?
We are seeking an experienced Regulatory/Quality Systems Engineer to join our team at JALEX Medical, LLC. In this role, you will be responsible for developing and implementing regulatory strategies to ensure compliance with FDA and international regulations.
The successful candidate will have direct support from leadership and team members through training and continuous learning. Our company offers a comprehensive benefits package and a very competitive salary commensurate with the role and your 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.
Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with FDA and international regulations
- Prepare and submit regulatory filings, including 510(k)s, PMA, and IDE applications
- Collaborate with cross-functional teams to develop and maintain quality systems and procedures
- Lead internal and supplier audits to ensure compliance with regulatory requirements
- Serve as a company representative during external audits by Regulatory and Third-Party Auditors
- Provide design control documentation assistance and validation testing protocol development
- Perform gap assessments against new and revised quality modules, quality directives, and ISO requirements
Requirements:
- Bachelor's degree in engineering, science, or health-related field
- 2 years of experience in the medical device industry
- Working knowledge of FDA and other regulatory authorities
- FDA regulatory submission experience
- International submission experience a plus
- Quality systems development, implementation, and training experience
- Direct experience working on processes within a quality system
- Experience with ISO 13485, FDA, MDR, and CMDR compliance requirements and training
- Experience with risk management per ISO 14971
- Self-starter, self-motivated, and results-oriented
- Excellent communication and project management skills
About JALEX Medical, LLC:
JALEX Medical, LLC is a leading medical device company committed to delivering innovative solutions that improve patient outcomes. Our team of experienced professionals is dedicated to ensuring the highest level of quality and regulatory compliance in all aspects of our business.
