Contract position: A Regulatory Affairs Consultant is needed for a leader in electronics, healthcare, and lighting in the Wallingford, CT area. This position will support regulatory compliance performing the required activities that assure compliance with FDA regulations for class III products. No per diem available. No travel is anticipated. 1st shift: 8:00 AM - 5:00 PM. Responsibilities for the Regulatory Affairs
Requirements for the Regulatory Affairs
- Handle or support regulatory requests from regulatory agencies, prepare and submit product registrations and submissions to FDA and other regulatory bodies.
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Bachelor's or Master's degree with at least 15 years of experience in a similar role.
- Serves as a subject matter expert in RA for new products. Must be familiar with product clearances, establishing licenses, maintaining files, communicating changes, evolving regulatory landscape, and quality system procedures.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.