Description
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cepheid, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Regulatory Affairs Specialist is responsible for supports the On-Market Sustainment Team by preparing global change notifications and updating technical documentation to maintain product approvals. This role is responsible for compiling and supporting regulatory submission packages across affected regions, ensuring compliance with local, regional, and global requirements. The specialist also contributes to planning activities, supports internal audits and inspections, and stays current with evolving regulatory policies. Additionally, the role involves training cross-functional teams and assisting with post-market regulatory activities.
This position is part of the Global QRC On-market Sustainment team and will be an on-site role in Bengaluru, India.
In this role, you will have the opportunity to:
+ Create, update, and maintain regulatory documentation and controlled files in compliance with global IVD and medical device regulatory standards
+ Prepare and deliver documentation packages for change registrations of Cepheid products, including required technical and regulatory artifacts
+ Identify, track, and apply local, regional, and global regulatory requirements using validated regulatory intelligence sources and databases
+ Assess regulatory changes for impact on product lines and associated functional areas, documenting applicability and required actions
+ Compile complete materials for regulatory submissions, license renewals, annual registrations, and internal/regional regulatory reports
The essential requirements of the job include:
+ Master’s degree with 2+ years of related experience, or Bachelor’s degree with 5+ years of experience in regulatory, compliance, or quality functions at a medical device or IVD manufacturing site
+ Demonstrated regulatory or scientific knowledge applicable to medical device or IVD manufacturing environments
+ Experience interpreting complex regulatory requirements and applying them to operational or compliance activities
+ Proven ability to address ambiguous regulatory or compliance issues and recommend appropriate actions within a regulated manufacturing setting
+ Ability to meet physical and operational requirements, including defined travel expectations, valid driver’s license with acceptable driving record, and capability to lift, move, or carry equipment up to 25 lbs.
It would be a plus if you also possess previous experience in:
+ Knowledge of Global IVD regulations and CE-IVDR a plus.
+ Prior knowledge of different databases like SAP, Agile, Trackwise etc. is preferred
+ Quality Control, Quality Systems, Assurance, Compliance
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
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.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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 www.danaher.com .
Operating Company: Cepheid
