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Regulatory Affairs Specialist II - Molecular LLC Cypress United States,  

Posted on : 07 May 2017

Project Description

Job Scope Your Mission Provide pre-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives for new and modified products. Supports applicable regulations including Local, State, Federal and/or International requirements. Main Responsibilities Your Contributions Provide direction on submission support, international registrations, and labeling to junior department members. Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions. Prepare global regulatory applications, as well as internal regulatory file documentation. Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations. Communicate with regulatory agencies on pre-market submissions related activities under the direction of management. Document consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc. Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends. Qualifications Experience Personal Strengths Mobility You Education Bachelor s Degree Specialization Life Science or Engineering Experience Three to five years of pre-market regulatory experience in the medical device industry or equivalent (education and work experience). Must have knowledge of U.S, Canadian, European and other International in vitro diagnostic regulations and standards. Should have experience working on project/product from concept to market introduction. Must have proven analytical capabilities, solid understanding of manufacturing processes, change control, regulatory principles and regulatory trends. US-RAC required with less than five years medical device experience. Preferred with greater than five years regulatory experience, but not required. Technical Competencies Must be able to work well in a team environment with individuals from diverse functional areas, as well as independently manage work. Must demonstrate leadership skills in team setting. Should have experience in presentation and negotiation of technical issues with internal and external functions including health authorities. Skills Must be detailed oriented. 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 ability to speak effectively before groups of customers or employees of organization. Requires the ability to 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 read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations. 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. Must have ability to calculate dilutions, titrations, and other laboratory methodologies. Must be skilled in basic algebra and geometry. Languages Fluent spoken and written English Travel Availability 0% Relocation Availability Domestic USA candidates only Training Required US-RAC required with less than five years medical device experience. Preferred with greater than five years regulatory experience, but not required. Benefits We Offer You As per local and Company requirements for DiaSorin Molecular LLC. Others Information as per Local Legal Requirements Must be 18 years of age, legally authorized to work in the US; and not require sponsorship for employment visa status (e.g, TN, H1B status) now or in the near future. It is the policy of DiaSorin to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, DiaSorin will provide reasonable accommodations for qualified individuals with disabilities. Our company uses E-verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit DiaSorin Molecular LLC is an EEO/AA employer. EEO is the Law (


Cypress United States

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