Danaher Corporation Regulatory Affairs Business Process Manager - REMOTE in Los Angeles, California
Essential job responsibilities:
Interact with departments to generate work instructions, protocols and report templates to expedite submission process and reduce the review timelines by the agencies.
Lead regulatory assessments in Agile, support the team in the review and approval of Change Orders.
Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes. Lead regulatory activities including planning and reviewing of regulatory submissions changes.
Track regulatory impact for anticipated changes and support global communication of changes.
Develop solutions to improve processes for regulatory submissions. Identify, implement, support validation and oversee software tools for organizing regulatory files, registration tracking and documentation for submissions.
Manage, guide, mentor and lead a team of 2 or more team members.
Review and generate a gap assessment report on new guidance and standards to provide to management and recommend follow-up measures.
Handle all aspects of the regulatory database as well as enhancements. Interact with global regulatory leaders and peers to share and manage department metrics and KPIs.
Provide regulatory training to cross-functional groups.
Support continued improvement to databases including TrackWise, ERP system, Business Intelligence databases and reports, Regulatory guidance documents, International standards databases and software.
Support and lead the regulatory module of the ERP system to streamline Regulatory Blocks and orders to meet On-Time Delivery to customers.
Education and Experience (in years):
High school diploma with 8+ years of experience OR
Bachelor’s degree with 5+ years of experience OR
Master’s degree with 3+ years of experience
Knowledge and experience with emphasis in regulatory/Quality or related departments within an IVD or Medical Device industry
Knowledge and skills:
Must have the ability to succeed in a fast-paced and changing innovative 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
Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
Travel – 20%
Someone with Master's or Bachelors with product change assessment and global authority notification experience in an IVD Regulated industry
Prior knowledge of different databases like SAP, Sales Force, Tarius, TrackWise etc. including Agile documentation system is preferred.
IVD product experience is highly preferred
Direct Management experience
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
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 email@example.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.