What are the responsibilities and job description for the Regulatory Affairs Manager position at JALEX Medical, LLC?
Responsibilities
The selected candidate will be responsible for ensuring compliance with regulatory requirements, identifying areas for improvement, and implementing corrective actions. The individual will also be involved in the development of Quality System procedures and processes, as well as performing internal and supplier audits.
Requirements:
• 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).
Skills and Qualifications:
• Self-starter, self-motivated, and results-oriented.
• Excellent interpersonal and written communication skills with high attention to detail in written work.
• Ability to work independently and with cross-functional internal and external teams.
