Danaher Corporation Manager, International Regulatory Affairs (Singapore) in Singapore, Singapore
ESSENTIAL JOB RESPONSIBILITIES:
Responsible for regulatory project timelines and management of international regulatory submissions.
Lead regulatory activities including planning, strategizing and reviewing of regulatory submissions.
Manage and coordinate regulatory submissions to ensure compliance with international regulations and guidelines.
Establish and assess Regulatory Affairs priorities as they relate to department and company goals and objectives
Maintain regulatory intelligence in areas of a competitive nature and keep abreast of changes in agency regulations and requirements
Interact 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
Perform regulatory assessments for anticipated analytical, manufacturing and packaging changes.
Support RA functional area in the review and approval of Change Orders.
Work in partnership with Quality department during internal and external audits for regulatory related tasks
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 and regions
Assess potential impact and/or applicability to other related areas
Provide regulatory training to cross-functional groups
Education or Experience (in years):
Bachelor s degree in Life Science or related 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:
Sound basis of Regulatory and/or 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 or manufacturing processes
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
IVD product experience is highly preferred
Travel – 20%
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
A minimum of 5 years of experience in Regulatory/Software Quality or related departments within an IVD or medical device industry is highly preferred
1-3 years management experience with at least 1-3 direct reports is preferred
Experiences in design and development process as well as project management is preferred
RAC certification 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) .
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