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Regulatory Affairs Manager

Company: Danaher
Location: Sunnyvale
Posted on: June 4, 2021

Job Description:

Job Responsibilities:

  • Responsible for regulatory project deliverables, timelines and submission activities for new product development (NPD) or sustainment projects
  • Lead regulatory activities for NPD projects including planning, preparing and submitting regulatory submissions
  • Manage, guide, coach and lead a team of 2 or more team members
  • Supervise submissions of staff and direct reports who are responsible for regulatory submissions
  • Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives
  • Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements
  • Interact with global regulatory leaders and peers to expedite approval of pending registrations
  • Manage and monitor multiple complex, novel and/or diverse projects simultaneously, including projects that involve several functional areas
  • Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes and sustainment projects
  • Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed
  • 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
  • Provide regulatory training to cross-functional groups as needed

Minimum Requirements

Education and Experience:

  • Bachelor's degree with 9 + years of experience OR
  • Master's degree with 7 + years of experience
  • Knowledge and experience with US submissions 510(k) and Pre-Submissions

Knowledge and Skills:

  • Strong history of regulatory approvals
  • Sound basis of regulatory and scientific knowledge
  • Must be detail oriented with well-developed organizational and analytical skills
  • Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
  • 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
  • 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 Qualifications:

  • Previous management and leadership experience preferred
  • Knowledge of IVDR, IVD, PMA submissions experience preferred

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 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.

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 to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.

Keywords: Danaher, Sunnyvale , Regulatory Affairs Manager, Other , Sunnyvale, California

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