Danaher Jobs

Job Information

Danaher Corporation Regulatory Affairs Specialist III (REMOTE) in Sunnyvale, California

Job Responsibilities

• Conduct post-market changes assessment

• Supports design changes and sustainment projects

•Actively participate in project core teams and collaboratively achieve project goals and meet timelines

•Partner with global and regional marketing in the development of regulatory plans

•Formulate short-term planning for individual deliverables and participate in long term planning within the organization

•Compile, prepare, review, and submit regulatory submissions including FDA pre-submissions, 510(k) and PMA submissions•Actively manage and monitor submissions under review. Respond promptly and negotiate with regulatory authorities, as needed. Track and manage regulatory review timelines•Provide regulatory input for product lifecycle management

•Provide training or presentations in multiple disciplines to cross-functional groups

Minimum Requirements

Education and Experience

Bachelor’s degree in a scientific discipline or related field with 5 years’ experience in a fast paced regulatory/compliance/quality team at a medical device developing and manufacturing site;

Master’s degree with 3+ years’ experience or

PhD with 0-2 years’ experience.

Knowledge and Skills

•Experience in post-market changes assessment and supporting design changes and sustainment projects

•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

•Ability to work independently and deliver on assigned tasks

•Effective communicator of technical & non-technical information

Preferred Qualifications

•Knowledge of IVDR, IVD, PMA submission requirements preferred

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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .