At Surgical Specialties Corporation, we are motivated by enabling our customers’ success. That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and service that will ensure the continued success of our company and the surgical professional well into the future.
Our precision manufacturing expertise along with our highly targeted sales and marketing capabilities help us offer novel and differentiated medical device products to patients and physicians, as well as to other medical device manufacturers and distributors.
Commitment to the Customer, Sense of Urgency, Focus, Accountability, and Teamwork define our culture and our organization and drive everything that we do.
We are seeking progressive, creative, customer oriented and highly skilled individuals for unparalleled opportunity.
Bring your passion, energetic vision, and entrepreneurial spirit to work for a company that will reward your commitment and encourage your potential. You can view current employment opportunities and apply online for a position with Surgical Specialties Corporation through our Online Career Center.
Reporting to the Vice President of Quality / Regulatory Affairs, the Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions and registration documentation. They also provide quality and timely regulatory support to obtain marketing clearance / approval for new products; devices/drugs, drug-device combinations and maintain marketability of existing products.
Education: Bachelor’s degreerequired in a technical discipline, such as Engineering, Bio-Medical Engineering, Computer Science, Biology or Chemistry. Masters Degreed preferred.
Experience: Minimum 8 – 10 years experience in Regulatory Affairs in the medical device/drug industry. Must have experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America. Must have experience with Standards (ISO, IEC and EN).