What are the responsibilities and job description for the Device Regulatory Specialist position at IntePros?
IntePros is seeking a qualified Device Regulatory Specialist 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 Job:
- This position requires a strong understanding of FDA regulations and guidelines for class II and class III products.
- You will work closely with Product Development and management to prepare and review 510(k) submissions.
- The successful candidate will have 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:
- Develop and implement compliance strategies to ensure our medical devices meet all regulatory requirements.
- Prepare and submit 510(k) documents to the FDA in a timely manner.
- Work closely with Clinical Data Manager and other Clinical Affairs personnel to obtain timely submissions to FDA.
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.
