Sr. Regulatory Affairs Specialist

  • Anywhere

Company :
Leica Biosystems

Location :
Sunnyvale, California

Expiry Date :
Mon, 26 Apr 2021 23:59:59 GMT

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Description :
At Cepheid, we are passionate about improving health care through faster, more accurate diagnostic tests. As a member of our team, you ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, as we develop rapid groundbreaking solutions to solve the world s most complex health challenges. Our associates are involved in every stage of molecular diagnostics from ideation and innovation through development and delivery of life-changing advancements in healthcare-associated infections, sexual health, critical infectious disease, virology and oncology applications. For more details, visit us at or follow us on Twitter. (@CepheidNews) As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life s Potential. POSITION SUMMARY: The Senior Regulatory Affairs Specialist will represent Regulatory Affairs on project core teams, perform the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections. The Sr. RA Specialist will compile all materials required in submissions, license renewal, and annual registrations. Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance as well as keep abreast of changes of new or updated regulatory policies and issued guidance. RESPONSIBILITIES: * Responsible for generation and maintenance of regulatory files * Responsible for generating and delivering documentation for registration of Cepheid products * Partner with global and regional marketing in the development of regulatory plans * Manages and monitor multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas * Maintains a "focused urgency" as required by specific events * Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas * Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors * Assesses potential impact and/or applicability to other related areas * Assesses corrective action to assure it prevents recurrence * Formulate short-term planning for individual deliverables and participate in long term planning within the organization * Prepare formal written reports/documents for distribution within work unit and regions * Provide training or presentations in multiple disciplines to cross-functional groups TRAINING RESPONSIBILITIES: (REQUIRED) * Complete all assigned and required training satisfactorily and on time MINIMUM REQUIREMENTS: Education and Experience: * Bachelor s degree in a scientific discipline or related field with 5 years experience in a regulatory team at a medical device company; Master s degree with 3 years experience or PhD with 0-2 years experience. Knowledge and skills: * Sound basis of regulatory and /or scientific knowledge * Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes * US submissions with 510K * Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations * Able to confidently deal with ambiguous issues and provide input towards suitable actions * Strong oral and written communication and presentation skills * Effective communicator of technical & non-technical information * Ability to work in a self-directed manner to see issues through to completion PREFERRED REQUIREMENTS: * IVD industry experience is highly preferred * Molecular diagnostics industry experience preferred * 2+ years experience in regulatory affairs Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.