Danaher Corporation Senior Manager, International Regulatory Affairs in Sunnyvale, California
ESSENTIAL JOB RESPONSIBILITIES:
Responsible for regulatory project timelines and management of global regulatory submissions.
Manage, guide, coach and lead a team of 2 or more team members which may include other RA Managers
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
Oversee through direct reports or may directly manage and monitor complex, novel and/or diverse projects, including projects that involve several functional areas
Support RA functional area in the review and approval of Change Orders.
Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes and sustainment projects
Lead regulatory activities including planning and reviewing of regulatory submissions.
Coordinate and prepare regulatory submissions to ensure compliance with international regulations and guidelines.
Interact with global regulatory leaders and peers to expedite approval of pending registrations
Interact with departments to generate protocols and reports that require in-country testing data for registration purposes
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
Assess corrective action to assure it prevents recurrence
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 + 9 years’ experience in the IVD or Medical Device industry
Master’s degree in a Life Science or related field + 7 years’ experience in the IVD or Medical Device industry
Knowledge and skills:
Demonstrate in-depth knowledge of regulatory requirements 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-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
Able to confidently deal with ambiguous issues and provide input towards suitable actions
Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations
Strong oral and written communication and presentation skills
Multitasks, prioritizes, and meets project deadlines in a timely manner
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
A minimum of 3-5 years managerial experience with 2-3 direct reports
Fluency in Spanish 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) .