Bengaluru Karnataka Regulatory affairs+ medical devices Jobs – 39 Open Jobs Today

Staff Regulatory Affairs - Bangalore
Beckman Coulter Life Sciences —Bengaluru, Karnataka
- Full-time
- Remote
- Master's degree
- Project management
- AI
- Paid time off
- Work from home
Regulatory Affairs Operations Analyst
BD —Bengaluru, Karnataka
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Regulatory Affairs Expert
Fresenius Medical Care —Bengaluru, Karnataka
- Full-time
- Engineering
- English
- Master's degree
5d
Regulatory Affairs Specialist
Masimo —Bengaluru, Karnataka
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Access
Regulatory Analyst - Clinical Affairs
Remidio —Bengaluru, Karnataka
- Bachelor's degree
- Communication skills
- Time management
Specialist - Regulatory Affairs - Operations 4A
Genpact India Pvt. Ltd. —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Data analysis skills
- English
- Master's degree
Quick apply
Senior Regulatory Affairs
Saraca Solutions —Bengaluru, Karnataka
- Bachelor's degree
- Travel
- Communication skills
Senior Regulatory Professional
Novo Nordisk —Bengaluru, Karnataka
- Doctoral degree
- English
- Master's degree
9d
QARA Executive
Oivi —Bengaluru, Karnataka
- Hybrid work
- Engineering
- Microsoft Office
- Bachelor's degree
Program Manager, Regulatory Affairs, Maternal Infant Care
GE HEALTHCARE —Bengaluru, Karnataka
- Microsoft Word
- Computer Science
- Word processing
Lead Engineer 1 - Safety & Regulatory Engineer
GE HEALTHCARE —Bengaluru, Karnataka
- Master's degree
- Analysis skills
- Project management
Sr. Quality and Regulatory Operations Specialist
Masimo —Bengaluru, Karnataka
- Full-time
- Analysis skills
- Bachelor's degree
- Communication skills
Manager Regulatory Affairs - IN
DeepHealth —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- Communication skills
Quick apply
Sr Regulatory Professional
Novo Nordisk —Bengaluru, Karnataka
- English
- Master's degree
- Bachelor's degree
3d
Lead - Regulatory Affairs
Dozee —Bengaluru, Karnataka
- Full-time
- Master's degree
- Bachelor's degree
- Business Administration
Sr. RA Operations Analyst
BD —Bengaluru, Karnataka
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Technical Writer - Manuals
Thermo Fisher Scientific —Bengaluru, Karnataka
- Full-time
- Spanish
- Writing skills
- English
Product Engineer,R&D
West Pharmaceutical Services —Bengaluru, Karnataka
- Customer service
- Project management
- Bachelor's degree
Manager I - BPM
UST —Bengaluru, Karnataka
Quick apply
4d
Director, Country Clinical Operations Management
AbbVie —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Customer service
- Analysis skills
- Project management
2d

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Staff Regulatory Affairs - Bangalore

Beckman Coulter Life Sciences -
Bengaluru, Karnataka

Apply Now

Job details

Full-time

Benefits

Paid time off
Work from home

Qualifications

Master's degree
Project management
AI
FDA regulations

Full job description

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 Life Sciences, one of Danaher’s 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 Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.

We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.

It’s all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we’re just beginning. Working together, let’s put our time and talents together to advance human health for tomorrow.

Learn about the Danaher Business System which makes everything possible.

The Staff Regulatory Affairs is responsible for driving compliance through Regulatory change and regulatory intelligence activities including but not limited to identification, interpretation, assessment and project management of changes. The purpose of this role is to maintain compliance with regulatory requirements on products and business systems and avoid audit observations and shipping delays.

This position reports to the Senior Manager, Regulatory Affairs and is part of the Global Quality and Regulatory affairs team and will be fully remote.

In this role, you will have the opportunity to:

Monitor and analyze global regulatory intelligence across: IVD and medical device regulations (e.g., EU IVDR, US FDA regulations and guidance),AI/Software regulations, Chemical and environmental regulations (e.g., EU REACH, RoHS, PFAS, EPA, EU CLP requirement)
Develop detailed assessments of regulatory changes, providing actionable insights and impact analyses for internal stakeholders. Create business cases for regulatory-driven changes, including cost, resource, and timeline impact for compliance activities.
Support global regulatory strategy development by providing intelligence-driven recommendations. Maintain regulatory intelligence repositories, dashboards, and communication tools.
Prepare and deliver regulatory intelligence briefings, cross-functional reports, and executive summaries.

· Leverage AI-enabled tools to automate horizon scanning and early detection of regulation changes· Lead compliance gap analyses and risk assessments to proactively identify areas of regulatory exposure and develop mitigation plans in partnership with Quality and Legal teams. Ensure alignment with internal SOPs and global regulatory standards.

The essential requirements of the job include:

Master’s degree in life sciences, engineering, or related field; advanced degree preferred.10+ years of experience in regulatory affairs or regulatory intelligence within the IVD/medical device industry.
Strong knowledge of global IVD regulations including FDA, EU IVDR, ISO 13485, ISO 20916, and related standards. Demonstrated experience managing regulatory compliance programs, including compliance tracking systems, and audit readiness activities.
Experience implementing regulatory intelligence systems or digital tools.
Experience with AI/software or chemical/environmental regulations strongly preferred
Experience interacting with regulatory agencies or notified bodies is a plus.

It would be a plus if you also possess previous experience in:

Previous experience in a regulatory intelligence role handling gap assessment and/or coordinating remediations

Beckman Coulter Life Sciences, 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.

At Beckman Coulter Life Sciences we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Life Sciences can provide.

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.

Apply Now

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regulatory affairs+ medical devices jobs in bengaluru karnataka

Staff Regulatory Affairs - Bangalore

Regulatory Affairs Operations Analyst

Regulatory Affairs Expert

Regulatory Affairs Specialist

Regulatory Analyst - Clinical Affairs

Specialist - Regulatory Affairs - Operations 4A

Senior Regulatory Affairs

Senior Regulatory Professional

QARA Executive

Program Manager, Regulatory Affairs, Maternal Infant Care

Lead Engineer 1 - Safety & Regulatory Engineer

Sr. Quality and Regulatory Operations Specialist

Manager Regulatory Affairs - IN

Sr Regulatory Professional

Lead - Regulatory Affairs

Sr. RA Operations Analyst

Technical Writer - Manuals

Product Engineer,R&D

Manager I - BPM

Director, Country Clinical Operations Management

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