Job Title: Director, Global Regulatory Affairs Business Process
Job Location: Sunnyvale, CA
The Director of Regulatory Affairs Business Process will lead a team that is responsible for managing the processes for tracking regulatory activities and providing department metrics to management, streamline registration process, manage regulatory blocks in ERP system, manage regulatory change process, utilize Danaher business tools to increase efficiency, manage international guidelines and standards and prepare the regulatory submissions as required.. Additionally, the Director of Regulatory Affairs Business Process will participate in international regulatory intelligence groups and represent Global Regulatory Affairs on industry committees as assigned.
ESSENTIAL JOB RESPONSIBILITIES:
Develop solutions to improve processes for regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions
Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements
Represent Cepheid in Medical Device associations and communicate to the team on upcoming guidances and standards.
Collect inputs from the team to provide comments to draft guidances and regulations.
Review and generate a gap assessment report on new guidances and standards to provide to management and recommend follow up measures.
Manage Regulatory database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics and KPIs.
Interact with departments to generate work instructions, protocols and report templates to expedite submission process and reduce the review timelines by the agencies
Manage Regulatory assessments in Agile, support the team in the review and approval of Change Orders.
Provide regulatory assessments for anticipated analytical, manufacturing and packaging Lead regulatory activities including planning and reviewing of regulatory submissions changes.
Support and manage regulatory module of the ERP system to streamline Regulatory Blocks and orders to meet On-Time Delivery to customers
Lead a team of direct reports, with overall responsibility to ensure proper staffing, coaching, development and performance appraisal
Contribute to the development and maintenance the Regulatory Affairs working practices and procedures
Effectively communicate comments/recommendations and proactively engage program teams to establish solutions to issues
Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs skill group
Review and approve timesheets and expense reports and guide the performance of assigned staff
Maintain a "focused urgency" as required by specific events
Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors
Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions
Assess potential impact and/or applicability to other related areas
Assess corrective action to assure it prevents recurrence
Provide regulatory training to cross-functional groups
TRAINING RESPONSIBILITIES: (REQUIRED)
Complete all assigned and required training satisfactorily and on time
For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
Education and Experience (in years):
Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level
A minimum of 14 years of experience in Regulatory Affairs and/or related departments within the IVD or Medical Device industry or 12+ years with a Master’s degree.
Minimum of 4 years in a supervisory role
Knowledge and skills:
Demonstrated people development and leadership experience
Ability, knowledge, and expertise to manage strategic regulatory programs
Demonstrated proficiency at conveying complex regulatory information to the business in a clear, focused and concise manner.
Must be detail oriented with well-developed organizational and analytical skills
Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment
Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
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
IVD product experience is highly preferred
Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
Prior knowledge of different databases like SAP, Sales Force, Tarius, Trackwise etc. including Agile documentation system is preferred.
Travel – 20%
Internal Number: R1122419
About Daniher / Cepheid
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, to develop rapid groundbreaking solutions for 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.
This important work takes more than just thinking, more than just leading, and more than simply doing – it takes all three. It takes people willing to bring their whole selves to work, operating with imagination, with initiative and achieving more than they ever thought possible.
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 pr...ofessional 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.
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.