Danaher Corporation Senior Regulatory Affairs Specialist in Sunnyvale, California
Essential job responsibilities:
Support product submission, renewal and change submission to ensure compliance with international regulations and guidelines with a focus in Greater China (Mainland China, Hong Kong, and Mongolia).
Responsible for regulatory project timelines and management of global submissions.
Lead regulatory activities including planning and reviewing of 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 stay on top of changes in agency regulations and requirements.
Engage with global regulatory leaders and peers to expedite approval of pending registrations
Collaborate with departments to generate protocols and reports that require in-country testing data for registration purposes.
Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
Support RA functional area in the review and approval of Change Orders.
Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed.
Maintain a "focused urgency" as the need arises 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 group
Training Responsibilities (required)
- Complete all assigned and required training satisfactorily and on time
Education and Experience
Bachelor’s degree in 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:
Regulatory and /or Scientific knowledge required
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-moving environment with ability to be flexible and adaptable within a changing multifaceted 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 sophisticated aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
Able to expertly 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
Ability to travel up to 20% of the time (mostly international)
Experience in Regulatory/Quality or related departments within an IVD or Medical Device industry is highly preferred
Experiences in experiment design and assay development process is highly preferred
Strong preference for technical background that could be assay development, R&D or familiarity with PCR
RAC certification or master’s degree is 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) .