The Regulatory Affairs Specialist reports to the Sr. Director, Regulatory & Clinical Affairs , North America and is based at our global Molecular business headquarters in Cypress, California.
This role will ensure compliance to FDA and other applicable regulations and regulating bodies. The Regulatory Affairs Specialist prepares, analyzes, and executes submissions to various governing agencies and, with their expertise, is a key contributor in the delivery of new and innovative products to our customers.
Monitor proposed regulatory changes from the FDA and other agencies including worldwide regulatory authorities
Maintain current knowledge and expertise of the regulatory landscape in order to provide expert input and guidance to the business.
Liaise with regulatory agencies on routine matters in addition to pre-clinical, pre-submission and submission discussions
Why people join DiaSorin
We are known for quality, excellence in customer care and innovative diagnostic products and instrumentation
We have energy, passion, drive and focus on delivering results because what we do impacts patients each and every day
We have dedicated and talented employees on our team with an excellent reputation within our industry
We are active in the communities in which we operate
We are guided by our strong ethical values
We are a global company headquartered in Saluggia, Italy with a large presence in North America
We offer a competitive total rewards package
Are you ready to make an impact at DiaSorin?
We seek out employees who are inspired by our mission and who thrive in our collaborative, fast paced and entrepreneurial culture.
Most important qualifications
Minimum Bachelor’s degree in Biology, Immunology, Microbiology, Biochemistry, Med Tech or related field is required
Minimum 5+ years experience regulatory affairs in medical device, pharmaceutical or biotechnology or in-vitro diagnostics (IVD) industry
U.S. and/or European/International regulations and standards knowledge is required
Prior experience with the FDA and/or other regulatory agencies is required
Proven analytical capabilities, solid understanding of manufacturing, change control, and awareness of regulatory industry trends
Additional Salary Information: We offer a competitive total rewards package
Internal Number: 1859
About DiaSorin Molecular
DiaSorin Molecular is dedicated to infectious disease diagnostic testing services, products, and information. We are focused on diagnostic solutions that can help improve the health of patients and populations that can help improve the world. Our company has continued to create a culture of innovation, quality, and personalized service, and we enjoy a reputation as a resource for infectious disease understanding that goes beyond the test. DiaSorin Molecular offers products used by hospitals, commercial laboratories, physicians and public health agencies to assist with the diagnosis, treatment and management of infectious diseases.