Regulatory Affairs Specialist II

03 Jun, 2020


Regulatory Affairs Specialist II

Sunnyvale, CA

– Responsible for regulatory project timelines and management of global regulatory submissions
– Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines
– Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives
– Interact with global regulatory leaders and peers to expedite approval of pending registrations
– Support internal and external departments to generate protocols and reports for registration purposes
– Maintain a “focused urgency” as required by specific events
– Recognize potential problems by actively reviewing and analyzing internal and external factors
– Assess potential impact and/or applicability to other related areas
– Provide regulatory training to cross-functional groups

– Complete all assigned and required training satisfactorily and on time


Education and Experience (in years):
– Bachelor’s degree in a Life Science or related field with 2+ years of direct experience in regulatory within an IVD or medical device manufacturing site OR
– Master’s degree in field with 0-2 years of related work experience

Knowledge and skills:
– 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
– Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a dynamic environment
– Able to confidently deal with ambiguous issues and provide input towards suitable actions
– Must be detailed oriented with well-developed organizational and analytical skills
– Highly proficient in Microsoft Word, Excel, PowerPoint and Adobe Acrobat
– 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

– International submissions of IVD product experience
– Prior experience with registration in South Korea
– Experience interfacing with Ministry of Food and Drug Safety in South Korea
– Fluency in Korean

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.

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Job posted: 2020-06-03