What are the responsibilities and job description for the Medical Device Compliance Specialist position at IntePros?
Company Overview
Job Description
Required Skills and Qualifications
IntePros is a growing Medical Device client based in Audubon, PA. Our company specializes in developing innovative medical solutions that improve patient outcomes.
Job Description
The Regulatory Affairs Specialist role is critical to ensuring compliance with FDA regulations and guidelines. The successful candidate will work closely with cross-functional teams to develop and implement regulatory strategies that support product development and commercialization.
Required Skills and 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
- 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
- Experience assessing regulatory impact of product/process changes
- Experience reviewing labeling, promotional literature, etc.
- Excellent communication and listening skills
- Proficient with Microsoft Office, including Word, Excel, PowerPoint, and Teams
- Strong time management skills, demonstrated ability to work on multiple projects, priorities simultaneously
- Able to work independently as well as within a team
