What are the responsibilities and job description for the Device Regulation and Submission Specialist position at IntePros?
About IntePros
IntePros is a leading provider of regulatory services for the medical device industry. Our team of experts has extensive experience in developing and implementing regulatory strategies that support product development and commercialization.
Responsibilities
- Partner with Product Development and Management teams to prepare and review 510(k) submissions;
- Prepare final 510(k) submissions and obtain required management approvals;
- Submit 510(k) documents and respond to the FDA in a timely manner;
- Assist in completing IDE and PMA submissions for IDE clinical trials;
- Help prepare PMA packages, including non-clinical, manufacturing, and clinical sections;
- Work with personnel in various functional areas to obtain timely submissions to FDA;
- Obtain and review clinical study data with Clinical Data Manager and other Clinical Affairs personnel;
- Review Document Change Orders for Regulatory compliance;
- Perform routine maintenance of approved PMAs;
- Train new staff on relevant Regulatory processes.
Qualifications
- Bachelor's degree in health or science-related field, or equivalent;
- Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry;
- Experience in medical device development and registration of products;
- Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus;
- Excellent communication and listening skills;
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams.
