Sr Regulatory Affairs Specialist-In Vitro Diagnostic
Location: US Remote or San Juan Capistrano, California
Provide regulatory guidance in IVD assay studies. The incumbent in this role will provide pre-market and regulatory strategy support to ensure regulatory approval objectives that support commercial initiatives. Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions. Must have the ability to understand and translate implications of regulatory requirements on company policies and strategies.
• Prepare global regulatory applications, as well as internal regulatory file documentation.
• Manage 510(k) submission & notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD 510k submissions, DE NOVO and other technical documentation, and global product registrations.
• Independently communicate with regulatory agencies on pre-market and post-market related issues.
• Document, consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc.
• Monitor proposed regulatory changes from the FDA and worldwide regulatory authorities and provide management with impact of changes in the Regulatory environment.
• Review related regulatory publications and documents to stay informed about current regulatory actions.
• Interface with industry associations to help state, federal, and international regulatory agencies develop regulations.
• Perform other duties as assigned
EDUCATION and EXPERIENCE:
BS/MS required, concentrations in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or related discipline preferred.
Must have extensive knowledge of U.S, Canadian, European and other International In vitro diagnostic regulations and standards.
At minimum five years of pre-market regulatory experience in IVD industry. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required.
Must be able to work well in team environment with individuals from diverse functional areas, as well as work independently.
Must have experience in negotiation of technical issues with internal and external functions including health authorities.
Must possess the ability to represent the Regulatory Affairs department to other departments within the company, and to represent the company to external agencies and organizations.
Requires the ability of organize information to compose reports, documents and presentations.
Requires knowledge of scientific, medical and regulatory terms.
Requires ability to understand and interpret regulatory requirements and technical standards.
Must have the ability to write and organize complex reports and correspondence to regulatory agencies. Requires ability to edit and proof documents with detailed accuracy.
Requires ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies, and the general public.
CERTIFICATES, LICENSES, REGISTRATIONS
US-RAC preferred but not required.
OSHA RISK CATEGORY
Category II - May encounter potential exposure.