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Danaher Corporation Senior Regulatory Affairs Process Specialist - REMOTE in Philadelphia, Pennsylvania

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications.

Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).

Make an Immediate Impact on a Global Scale At Cepheid, the work you do every day will impact patient care around the world.

You’ll be inspired and invigorated, knowing that you’re part of the team helping to diagnose the most challenging diseases. And you can be proud knowing you work for a company with the highest integrity, creating the quality products clinicians around the world depend on to deliver better, faster diagnosis for the most vulnerable patients.

The Regulatory Affairs Process Specialist will work with the TrackWise Regulatory Submission Tracking software database to update information and create new workflows. They will work with IT to build new workflow structures, define Work Instructions, and train the team on the TrackWise processes. They will support SAP processes related to Regulatory functionality and maintain accurate listing of blocked and released product within SAP.

POSITION SUMMARY:

The Regulatory Affairs Process Specialist will work with the TrackWise Regulatory Submission Tracking software database to update information and create new workflows. They will work with IT to build new workflow structures, define Work Instructions, and train the team on the TrackWise processes. They will support SAP processes related to Regulatory functionality and maintain accurate listing of blocked and released product within SAP.

ESSENTIAL JOB RESPONSIBILITIES:

  • Investigate and implement continuous improvement to databases including TrackWise, ERP system, Business Intelligence databases and reports, Regulatory guidance documents, International standards databases and additional software.

  • Maintain and manage regulatory module of the ERP system to streamline Regulatory Blocks and orders to meet On-Time Delivery to customers.

  • Interact with departments to generate work instructions, protocols and report templates to expedite submission process and reduce the review timelines by the agencies.

  • Track regulatory impact for anticipated changes and maintain accurate listing of blocked and released product within the ERP system (SAP).

  • Develop solutions to improve processes for regulatory submissions and tracking. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking, documentation for submissions and regulatory blocks/approvals.

  • Collect inputs from the regulatory team to provide comments to the draft guidance documents 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.

  • 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

MINIMUM REQUIREMENTS:

Education and Experience (in years):

  • Bachelor s degree in Life Science or related field with 5+ years of related work experience OR

  • Master’s degree in field with 3+ years of related work experience OR

  • Doctoral degree in field with 0-2 years of related work experience.

Knowledge and skills:

  • Sound basis of Regulatory and /or Scientific knowledge

  • Sound basis of process/procedure knowledge and training experience 

  • Strong PowerPoint, Excel, Word and Visio knowledge 

  • 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 regulation 

  • 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 

  • Prior knowledge of different databases like SAP, Sales Force, Tarius, Trackwise etc. including Agile documentation system is preferred

    #LI-REMOTE

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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