Danaher Corporation Regulatory Affairs Specialist III - REMOTE in South San Francisco, California
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).
Are you a Regulatory Affairs Specialist with US or Global experience with the expertise to prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus in South-East Asia and South Korea?
Make an Immediate Impact on a Global Scale At Cepheid, the work you do every day will impact patient care around the world.
You’ll be inspired and invigorated, knowing that you’re part of the team helping to diagnose the most challenging diseases. And you can be proud knowing you work for a company with the highest integrity, creating the quality products clinicians around the world depend on to deliver better, faster diagnosis for the most vulnerable patients.
Preference is to be located in Sunnyvale but may have option to be Remote.
ESSENTIAL JOB RESPONSIBILITIES:
Support product submission, renewal, and change submission to ensure compliance with international regulations and guidelines.
Ensure proper filing and organization of all documents and correspondence in support of and concerning all regulatory submissions.
Responsible for regulatory project timelines and management of global 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.
Collaborate with internal and external departments to generate protocols and for registration purposes.
Engage with global regulatory leaders and peers to expedite approval of pending registrations
Communication with and maintain productive, constructive relationships with external customers as required – regulatory authorities, in-country affiliates, and/or distributors.
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 (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:
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 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
Experience in Regulatory 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
Experience in working with South-East Asian and/or South Korea regulatory authorities
RAC Certification preferred
Proficiency in a foreign language is a plus
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at 202.419.7762 or email@example.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid