Contract position: A manufacturer of optics products is seeking a Senior Regulatory Affairs Specialist in the Center Valley, PA area. This is a 1-year CONTRACT position. No per diem available.
Responsibilities for the Regulatory Affairs
- Represent Regulatory Affairs in product teams developing new products to define global regulatory requirements. Responsible for developing of Global Regulatory Pathway Assessment strategy document.
- Review and approve product labelling (including IFU review). Work closely with Upstream Marketing and the Regulatory Compliance Team in developing labelling materials.
- Assist with maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management.
Requirements for the Regulatory Affairs
- Bachelor's degree preferably in Engineering. At least 5 years of regulatory affairs experience in the medical device industry is mandatory.
- Experience with software driven, and stand-alone medical device software and IEC 62304 software development lifecycle is desired.