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Senior Regulatory Affairs Specialist

2 months ago

Centennial, United States EUROFINS VRL INC. Full time

Location field must contain 'city, state' or a zip code to perform a radius search (e.g.,

Denver, CO

or

46122 ). City and state must be separated by a comma followed by a space (e.g.,

Houston, TX ) EUROFINS VRL INC.

Senior Regulatory Affairs Specialist

in

Centennial ,

Colorado

Company Description Eurofins Scientific is an international life sciences company, whichprovides a unique range of analytical testing services to clients acrossmultiple industries. The Group believes it is the world leader in food,environment, pharmaceutical and cosmetics products testing and inagroscience CRO services. It is also one of the global independent marketleaders in certain testing and laboratory services for genomics, discoverypharmacology, forensics, CDMO, advanced material sciences and forsupporting clinical studies. In addition, Eurofins is one of the leadingglobal emerging players in specialty clinical diagnostic testing. In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800laboratories across 47 countries, employing about 45.000 staff. Eurofins stands for a conception of clinical diagnostics entirely focused onexcellence, innovation and technological investment. Eurofins clinicaldiagnostics offers testing services in all medical specialties. As a central element in healthcare, clinical diagnostics contributes toevery stage of patient care: predisposition, prevention, diagnostics,treatment monitoring and prognosis. With hundreds of thousands of clinical diagnostics tests performed everyday, the laboratories of the clinical diagnostics division strive to ensurethat every patient, wherever he or she lives, has access to the mostspecialized and most innovative techniques for diagnosis, monitoring andtherapeutic adjustment. Our logistics expertise and our daily samplecollection and delivery network, guarantee perfect continuity in theprovision of care while ensuring the same standard of quality and access toinnovation across all the regions we serve. Job Description Senior Regulatory Affairs Specialist responsibilities include, but are notlimited to, the following: Under the direction of the Manager, Regulatory Affairs and QualityAssurance, this position in tandem with Senior Management, will assistwith ensuring that DPT's laboratories are compliant with the regulatory andaccrediting organizations that oversee our laboratories. This position works closely and collaboratively with other functional areasthroughout the network of laboratories. Evaluates the regulatory environment and contributes to providing internaladvice on regulatory and accrediting compliance. Anticipates regulatory obstacles and emerging issues related to laboratorytesting and the transplant industry/ community. Assists in the development of regulatory strategy and updates strategy basedupon regulatory changes, as appropriate. Provides regulatory information and guidance to the regulatory groups andothers within the organization. Identifies the need for new regulatory procedures, SOPs, andparticipates in development, training, and implementation of theregulatory processes. Helps train stakeholders on current and new regulatory requirements toensure organization-wide compliance. Assists other departments in the development of SOPs to ensure regulatorycompliance, as needed. Provides regulatory input and technical guidance on applicable internationalregulatory requirements. Communicates and interacts with regulatory and/or accrediting authoritiesthrough appropriate communication tools. Works with cross-functional teams for interactions with regulatoryauthorities. Accountable for the organization, research, communication,maintenance, and growth of the DPT Regulatory Intelligence Library andaddressing all regulatory inquiries in a timely manner. Maintains list of all applicable Standards and Regulations which apply toall DPT facilities. Maintains DPT regulatory licensing, certification and permits for allfacilities including renewals, assay change notifications, site or labdirector changes, etc. including updating and maintaining current regulatorystatus on websites (CAP.org, NYS HCS) nd internal tracking spreadsheets(submissions, licenses/permits, etc.) Manages and maintains industry standards and guidance subscriptions,maintains relationships with industry organizations and communicates anyoutput to stakeholders. Interprets and applies FDA and other industry regulations and standards tobusiness practices and fit for purpose. Writes, edits, and maintains departmental standard operating procedureswith management and team. Coordinates the internal Audit schedule and assign auditors as necessary tomeet the scope and expectations of the schedule. Perform internal audits inauditor or lead auditor role. Organizes and compiles information for inspection/audit responses. Represents Eurofins DPT in lead or supporting role (e.g., host) forregulatory-based audits/inspections. Provide external auditors withrequested information, ensure documentation is complete and accurate, andcollaborate with operational staff for tours and interviews. Maintains and utilizes working knowledge of applicable regulations,standards and policies; keep current with all relevant federal, state andlocal regulations and standards. Performs duties and tasks in a timely and compliant manner, ensuringaccurate documentation and conclusions.

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