What are the responsibilities and job description for the Compliance and Regulatory Professional position at IntePros?
We are looking for a highly skilled Compliance and Regulatory Professional to join our team at IntePros. As a key member of our team, you will be responsible for ensuring that our medical devices comply with all relevant regulations and guidelines.
About the Position:
- This role 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.
Key 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.
Requirements:
- 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.
