.png){kind=logo}
Beckman Coulter
Apply for Regulatory Affairs Analyst role at Beckman Coulter in Bangalore. Openings for Life Science/Engineering graduates with 8–10 years’ experience.
Do you want to accelerate your potential and make a meaningful difference in the life sciences and diagnostics industry? Beckman Coulter Life Sciences, part of the Danaher group of companies, is hiring a Regulatory Affairs Analyst in Bangalore. This role provides the opportunity to contribute to global product registrations, compliance, and innovation that ultimately improves patient outcomes worldwide.
Company Overview
Beckman Coulter Life Sciences, established in 1935, is a pioneer in providing cutting-edge laboratory solutions that help scientists and clinicians deliver life-saving therapies faster. As part of Danaher’s 15+ operating companies, Beckman Coulter focuses on accelerating answers in healthcare by automating workflows, reducing errors, and driving efficiency in labs worldwide.
With more than 3,300 colleagues globally, many of whom are scientists, the company is deeply committed to advancing human health through technology, innovation, and regulatory excellence.
Job Role & Responsibilities
As a Regulatory Affairs Analyst, you will be responsible for supporting global regulatory submissions and ensuring compliance across product lifecycles. Key responsibilities include:
- Preparing registration dossiers for life sciences products across multiple countries (excluding the USA).
- Gathering and maintaining technical documentation for new product development.
- Ensuring documentation complies with evolving global regulatory requirements.
- Supporting product lifecycle management including design changes, labeling updates, and compliance improvements.
- Assessing regulatory impact and creating detailed action plans for timely compliance.
- Supporting global pre-market regulatory submissions such as Q-Subs, 510(k), IVDR, China registrations, and other global filings.
- Maintaining compliance with international standards such as ISO 13485, ISO 9001, IVDD/IVDR, and other applicable regulations.
- Supporting regulatory activities related to Software as a Medical Device (SaMD) and software used as accessories to medical devices.
Eligibility / Qualifications
Minimum Requirements:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- 8–10 years of regulatory affairs experience in a regulated medical device or diagnostics industry (less with advanced degrees).
- Experience with global regulatory submissions, including premarket filings.
- Familiarity with international quality systems (ISO 13485, ISO 9001).
- Experience with Software as a Medical Device (SaMD) preferred.
Preferred Skills & Certifications:
- Regulatory or quality certifications (e.g., CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean).
- Experience in instrument and software development within the medical device sector.
- Strong project management, adaptability, and communication skills.
- Ability to work flexible hours to support global business operations.
Location & Salary
- Location: Bangalore, Karnataka, India
- Job Type: Full-time | On-site
- Salary: Competitive with eligibility for bonus/incentive pay
- Benefits: Comprehensive healthcare, paid time off, career development, and global exposure under Danaher’s continuous improvement system
Application Process
Interested candidates can apply through the official Danaher careers portal. Don’t miss your chance to join a world leader in diagnostics and regulatory excellence.
FAQs
1. Who can apply for this role?
Life Sciences or Engineering graduates with 8–10 years of regulatory experience in diagnostics or medical devices.
2. What regulatory standards should candidates be familiar with?
Standards such as IVDR, IVDD, ISO 13485, ISO 9001, and other applicable global quality systems.
3. Is software regulatory experience required?
Yes, experience with SaMD or software as a medical device accessory is highly desirable.
4. What certifications are advantageous?
Certifications like RAC, Six Sigma, Lean, CQA, CQE add significant value.
5. How can I apply?
Apply directly through the official Danaher Careers Website.
Call to Action
Join Beckman Coulter Life Sciences and be part of a global team that accelerates answers for critical healthcare needs. Apply today for the Regulatory Affairs Analyst position in Bangalore and take your career in regulatory affairs to the next level.
Apply before the position closes to secure your opportunity!
Job Summary Table
| Company | Beckman Coulter Life Sciences (Danaher) |
|---|---|
| Vacancies | Regulatory Affairs Analyst |
| Required Education | Bachelor’s in Life Sciences, Engineering (Advanced degrees preferred) |
| Experience | 8–10 years in Regulatory Affairs (Medical Devices/Diagnostics) |
| Location | Bangalore, Karnataka, India |
To apply for this job please visit jobs.danaher.com.