What are the responsibilities and job description for the Regulatory Affairs Expert position at IntePros?
At IntePros, we are seeking a skilled Regulatory Affairs Expert to join our team in the Medical Device industry. This role is focused on ensuring compliance with FDA regulations and guidelines for class II and class III products.
About the Role:
- We are looking for an individual with experience in medical device development and registration of products.
- The successful candidate will have a strong understanding of US regulatory submissions, including 510(k), IDE, and PMA.
- This position requires excellent communication and listening skills, as well as proficiency in Microsoft Office.
- Able to work independently and within a team, this role involves developing relevant SOPs and assessing the regulatory impact of product/process changes.
Responsibilities:
- Partner with Product Development and management to prepare and review 510(k) submissions.
- Prepare final 510(k) submissions and obtaining required management approvals.
- Submit 510(k) documents and responding to the FDA in a timely manner.
- Assist in the completion of IDE and PMA submissions for IDE clinical trials.
Qualifications:
- Bachelor's degree in health or science-related field, or equivalent; Engineering degree is a plus.
- Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, preferably within orthopedic medical devices.
- Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus.
- Experience assessing regulatory impact of product/process changes.
