Category: Scientific & Clinical
Job Title: Sr. Regulatory Affairs Specialist
Location: Lehigh Valley, PA Area
Type: Full time, salaried with benefits
Start Date: Immediate
Medical Device Company is currently hiring for a Senior Regulatory Affairs Specialist to join their team!
- Support project teams with regulatory activities in relation to PMA, 510(k), Design Dossiers and other regulatory responses
- Prepare various regulatory submissions for approval/registration
- Respond to FDA requests for additional information
- Provide technical support for the preparation of international registrations for non-US, non-EU product registrations
- Determine requirements for filing annual reports, 30 day notices or PMA supplements
- Ensure procedures are kept up to date with changing standards, regulations and guidance documents
- Bachelor's Degree in Life Sciences, Physical Sciences or Engineering
- 4 years of experience in the manufacturing or development of medical device field or other related field in the FDA
- Regulatory Affairs experience in the medical device industry
- Experience in writing documentation for submission to the FDA, other regulatory authorities, etc.
- Experience with design control, risk management and validation experience relating to medical device
- International registration experience
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.