Analyst I Regulatory Affairs
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Job Location:
Sacramento, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
At Beckman Coulter Diagnostics one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.
As a global leader in clinical diagnostics Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratorys role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing and are used in hospitals reference and research laboratories and physician offices around the world. Every hour around the world more than one million tests are run on Beckman Coulter Diagnostics systems impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough to rapid and reliable sample analysis to more rigorous decision makingwe are enabling clinicians to deliver the best possible care to their patients with improved efficiency clinical confidence adaptive collaboration and accelerated intelligence.
Learn about the Danaher Business System which makes everything possible.
The Regulatory Analyst I is responsible for supporting global regulatory strategies for microbiology-based IVD products including antimicrobial susceptibility testing (AST) systems. This role ensures compliance with FDA and EU IVDR requirements and assists in preparing regulatory submissions and technical documentation.
This position reports to the Sr. Director QRC Microbiology and is part of the Regulatory Affairs Team located in West Sacramento CA and will be an on-site role.
In this role you will have the opportunity to:
- Assist in preparing and maintaining regulatory submissions (e.g. 510(k) Technical Documentation).
- Support cross-functional teams (R&D Clinical Affairs Quality) to meet regulatory requirements throughout the product lifecycle.
- Learn and apply FDA and IVDR regulations guidance documents and standards (ISO 13485 ISO 14971).
- Contribute to regulatory strategies for new product development and changes.
- Support responses to regulatory agency inquiries and audits.
The essential requirements of the job include:
- Education: Bachelors degree in microbiology biology biomedical engineering or related scientific discipline.
- Experience: 02 years in regulatory affairs or related functions in IVD or medical device industry (internship or co-op acceptable).
- Basic understanding of FDA regulations (21 CFR 809 820) and EU IVDR (2017/746).
- Strong written and verbal communication skills.
- Detail-oriented with good organizational and time management skills.
It would be a plus if you also possess previous experience in:
- Familiarity with microbiology-based diagnostics or AST systems.
- Exposure to regulatory submissions (510(k) IVDR Technical Documentation).
- Regulatory Affairs Certification (RAC) or willingness to pursue.
Beckman Coulter Diagnostics a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $100-120K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
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Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.
For more information visit .
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.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more
