Regulatory Affairs Jobs | Cepheid is Hiring a RA Specialist | Apply Now
Looking to advance your career in life science with global impact? Cepheid, a Danaher operating company, is hiring a Regulatory Affairs Specialist for its on-site team in Bengaluru. This role offers excellent exposure to global regulatory processes and is ideal for professionals seeking growth-oriented regulatory affairs jobs within diagnostics and biotechnology while building a strong Cepheid career.
Job Details
- Job Title: Regulatory Affairs Specialist
- Location: Bengaluru East, Karnataka, India
- Type: On-site, Full-time
About the Company
Cepheid is a global leader in molecular diagnostics and a proud operating company of Danaher. The company develops fast, accurate diagnostic systems that help clinicians make critical decisions and improve patient outcomes worldwide. Cepheid operates with a strong focus on quality, innovation, and regulatory excellence. Backed by the Danaher Business System, the organization fosters continuous improvement and professional growth. Cepheid offers a collaborative environment for professionals pursuing a meaningful career in life sciences. Its solutions play a vital role in addressing complex global health challenges.
Key Responsibilities
- 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 functional areas, documenting applicability and required actions
- Compile complete materials for regulatory submissions, license renewals, annual registrations, and internal/regional regulatory reports
Qualifications
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
Skills Required
- 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
- Ability to meet physical and operational requirements, including the capability to lift, move, or carry equipment up to 25 lbs.
Additional Requirements (Peferred)
- Knowledge of Global IVD regulations and CE-IVDR
- Familiarity with databases like SAP, Agile, Trackwise
- Quality Control, Quality Systems, Assurance, Compliance
This role is an excellent opportunity for professionals seeking impactful regulatory affairs jobs in diagnostics and biotechnology. With exposure to global regulatory processes, continuous learning, and Danaher’s innovation culture, this position supports long-term growth and stability in a Cepheid career and a rewarding career in life science
