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About our client
Our client is a diagnostics company based in California, with their head office in New York. They offer products and services used by the industry to assist with the diagnosis, treatment and management of infectious diseases. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees.
Position	Location
Senior Regulatory Affairs Specialist	South California
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Ensure compliance with FDA and other applicable regulations 2) Prepare, analyze and submit dossiers to various governing agencies for supporting business growth 3) Support applicable regulations, including ISO, local, state and/or federal requirements 4) Monitor proposed regulatory changes from the FDA, worldwide regulatory authorities and other regulatory agencies 5) Provide the management with impact of changes in the regulatory environment 6) Review related regulatory publications and documents to stay informed about current regulatory actions 7) Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission and submission discussions 8) Participate in training and education seminars (as appropriate) to learn regulatory requirements and demonstrate RA knowledge 9) Document, consolidate and maintain communications (oral and written) with FDA, notified bodies and clinical investigators 10) Assist with filing annual notifications, annual establishment (state and federal registrations) and product changes of FDA, Health Canada, EU, notified bodies, etc. 11) Compile and submit device experience reports as per FDA Medical Device Reporting System, EU Device Vigilance System, etc. 12) Support the design control process by providing regulatory review for design control binders 13) Ensure consistent application of law, regulation and guidance across design projects 14) Participate in and conduct internal audits 15) Interact with responsible departments to manage collection, reviewing and assembly of scientific, clinical, manufacturing and administrative sections of submissions to regulatory agencies 16) Participate in third party audits (e.g. FDA, State of California, Notified Body, etc.) of the quality management system 17) Assist in developing responses to support audit corrections and rebuttals 18) Participate in product recovery process and generate regulatory risk assessments for product issues with customer exposure 19) Maintain external references along with lists of national and international regulations, standards and FDA guidance documents that affect the products and operations 20) Assist with development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information 21) Review change control documents and ascertain the regulatory impact of external and internal documents 22) Support distribution and purchasing in export/import of raw materials and product 23) Acquire RUO/IUO agreements, CDC import permits and USDA import permits 24) Obtain pathogen import/export permits 25) Communicate and interface with international sales managers and international distributors to assist in international regulatory issues 26) Coordinate the notarization and legalization of regulatory documents 27) Develop and manage regulatory strategies to facilitate clinical studies and submission within business plan timelines 28) Interface with industry associations to help state, federal and international regulatory agencies to develop regulations 29) Assist with patent advice 30) Review and edit submissions prepared by other RA staff 31) Assist lab with FDA interface 32) Provide back up to the Regulatory Affairs Manager (as needed)
Requirements
1) BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or a related discipline 2) 5 – 15 years of experience in a regulatory affairs environment for a medical device, pharmaceutical or biotech industry 3) Experience in working on a project/product (from concept to market introduction) 4) Experience in negotiating technical issues with internal and external functions, including health authorities 5) Knowledge of US and/or European/International regulations and standards 6) Expertise in preparing regulatory submissions on drug, device and biologic products preferred 7) In-depth understanding of manufacturing and change control as well as an awareness of regulatory trends 8) Experience in interacting with FDA staff and/or other regulatory agencies 9) Demonstrated success in securing regulatory approvals preferred 10) Ability to work independently and in a team environment with individuals from diverse functional areas 11) Superb leadership skills in a team setting 12) Excellent analytical abilities