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Specialist, Regulatory Affairs - Sr
* Review related regulatory publications and documents to stay informed about current regulatory actions.
* Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions.
* Participate in training and education seminars as appropriate to learn regulatory requirements and other regulatory affairs skills.
* Support Design Control process by providing Regulatory review for Design Control binders and ensuring consistent application of law, regulation, and guidance across design projects.
* Interact with responsible departments to manage collection, review, and assembling of the scientific, clinical, manufacturing, and administrative sections of submissions to regulatory agencies.
* Participate in and/or conduct Internal Audits.
* Participate in Product Recovery process and generate regulatory risk assessments for product issues with customer exposure.
* Maintain External References and lists of national and international regulations, standards and FDA guidance documents that affect the products and operations.
* Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information. Review change control documents and ascertain Regulatory impact for external and internal documents.
* Support distribution and purchasing in export/import of raw materials and product.
* Obtain pathogen import/export permits.
* Communicate and interface with International Sales Managers and International Distributors to assist in international regulatory issues.
* Coordinate the notarization and legalization of regulatory documents.
* Develop and manage regulatory strategies to facilitate clinical studies and submission within business plan timelines.
* Coordinate interface with industry associations to help state, federal, and international regulatory agencies develop regulations.
* Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related programs and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
* Perform other duties as assigned.
BS/MS in Biology, Immunology, Microbiology, Biochemistry, Medical Technology or related discipline required and 5 years experience working in a regulatory affairs environment for a medical device, pharmaceutical or biotech industry required; or more than 10 years experience working in an IVD regulatory affairs environment.
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