Bengaluru Karnataka Regulatory affair Jobs – 43 Open Jobs Today

Head- Regulatory Affairs (Sales & Services)
Siemens Healthineers —Bengaluru, Karnataka
- Full-time
- Doctoral degree
- Master's degree
- Bachelor's degree
LifeScience Regulatory Svs Sr Analyst
Accenture —Bengaluru, Karnataka
- Full-time
Sr. Manager- Regulatory Affairs
Motherson —Bengaluru, Karnataka
- Full-time
- Management
- Master's degree
- Bachelor's degree
#ACN-GN-Industry Life Science R&D Regulatory
Accenture —Bengaluru, Karnataka
- Full-time
- Master's degree
- AI
- MBA
Senior Scientist (Bio-Analytical and Bio-Assay)
Perfect Day India Pvt Ltd —Jigani, Bengaluru, Karnataka
- Full-time
- Laboratory experience
- Research
- Master's degree
Quick apply
11d
Director, Country Clinical Operations Management
AbbVie —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Customer service
- Analysis skills
- Project management
Site Start Up EUCTR II
Parexel —Bengaluru, Karnataka
- Microsoft Powerpoint
- Microsoft Office
- Databases
14d
Assoc Director - Publishing
Novo Nordisk —Bengaluru, Karnataka
- Master's degree
- Leadership
- Communication skills
4d
LifeScience Regulatory Svs Manager
Accenture —Bengaluru, Karnataka
- Full-time
- Master's degree
Sr Clinical Database Programmer
Veranex, Inc. —Bengaluru, Karnataka
- Full-time
- Computer Science
- Databases
- Bachelor's degree
Quick apply
2d
R&D India Site Head
Bayer —Bengaluru, Karnataka
- Call employer
- Master's degree
- Project management
- Software development
Principal Regulatory Services Advisor
Accenture —Bengaluru, Karnataka
- Full-time
- Master's degree
Manager - Submission Management
Merck KGaA —Bengaluru, Karnataka
- Leadership
2d
Senior Director, Head of R&D Global Capability Centers (GCC) - India
Takeda Pharmaceutical —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Travel
- AI
- Leadership
Chief Financial Officer (CFO)
The/Nudge Institute —Bengaluru, Karnataka
- Master's degree
- Analysis skills
- MBA
Senior Specialist Submission Management
Merck KGaA —Bengaluru, Karnataka
- Doctoral degree
- Master's degree
- Communication skills
1d
Associate Director, QCP Lead
Takeda Pharmaceutical —Bengaluru, Karnataka
- Full-time
- Doctoral degree
- Pediatrics
- AI
- Health insurance
- Cell phone reimbursement
BC Sector LS-centre for reimagination-Senior Manager
EY —Bengaluru, Karnataka
- AI
- Leadership
2d
Principal Clinical Data Manager
Veranex, Inc. —Bengaluru, Karnataka
- Computer science
- Databases
- Project management
Quick apply
Director, Quantitative Clinical Pharmacology Lead
Takeda Pharmaceutical —Bengaluru, Karnataka
- Full-time
- Doctoral degree
- Pediatrics
- AI
- Health insurance
- Cell phone reimbursement

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Head- Regulatory Affairs (Sales & Services)

Siemens Healthineers -
Bengaluru, Karnataka

Apply Now

Job details

Permanent | Full-time

Qualifications

Doctoral degree
Master's degree
Bachelor's degree
Business Administration
AI
MBA
Leadership
Communication skills
Negotiation
FDA regulations

Full job description

The Head of Regulatory Affairs will lead the regulatory function for Healthineers, Zone India, ensuring compliance with national and international regulations while supporting the company’s strategic objectives. This role requires an experienced leader who can navigate the dynamic regulatory environment, advocate for the company’s interests, and enable the successful registration, approval, and lifecycle management of medical devices in the Indian market.

The individual will act as the primary point of contact with regulatory authorities, including the Central Drugs Standard Control Organization (CDSCO), and drive cross-functional collaboration to align business goals with regulatory requirements. Additionally, they will play a critical role in ensuring the organization adheres to evolving global standards and supports innovation while maintaining the highest levels of safety, quality, and compliance.

Key Responsibilities

1.Regulatory Strategy Development

Define and drive the regulatory vision and strategy for CRM products, aligning with Healthineers business goals.
Establish a roadmap for regulatory submissions, approvals, and compliance for new and existing product lines.
Lead initiatives to address regulatory challenges in emerging areas, such as digital health, artificial intelligence, and interoperability.

2.Leadership and Team Management

Build and lead a high-performing regulatory team, fostering a culture of excellence, innovation, and accountability.
Provide mentorship and professional development opportunities to regulatory staff.
Act as the primary regulatory advisor to the leadership team, providing guidance on risk management and compliance.

3.Regulatory Submissions and Approvals

Oversee the preparation, submission, and maintenance of regulatory dossiers.
Ensure timely guidance and approval while managing regulatory interactions and inspections.
Advocate for streamlined regulatory pathways by engaging with regulators and industry groups.

4.Compliance Oversight

Ensure that our equipment’s meet the required regulatory standards as set by CDSCO.
Oversee the implementation of risk management frameworks, including adherence to ISO 13485 and knowledge of SaMD products which must comply with IEC 62304 (Software Lifecycle Processes) and ISO 14971 (Risk Management).
Lead regulatory responses to audits, inspections, and post-market surveillance requirements.

5.Cross-functional Collaboration

Partner with Govt affairs, Quality, Business Areas, Marketing and Legal team to integrate regulatory requirements.
Provide regular updates and input to ensure compliance with applicable standards.
Support with strategies by aligning regulatory timelines with market goals.

Qualifications

Education: Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related fields. Advanced degrees (e.g., MBA, Ph.D.) are an advantage.

Experience:

Minimum 10–15 years of regulatory experience, with at least 5 years in a leadership role.
In-depth understanding of India’s Medical Devices Rules, 2017, CDSCO guidelines, and applicable standards (e.g., ISO 13485, ISO 14971).
Familiarity with global regulations like FDA (21 CFR), EU MDR/IVDR, and other regional requirements for international market access.
Proven track record of managing regulatory strategies for medical device company.
Exceptional leadership, communication, and negotiation skills.
Strategic thinker with a proactive approach to problem-solving.
Ability to navigate complex regulatory landscapes while maintaining agility.

Apply Now

Refine Your Search

regulatory affair jobs in bengaluru karnataka

Head- Regulatory Affairs (Sales & Services)

LifeScience Regulatory Svs Sr Analyst

Sr. Manager- Regulatory Affairs

#ACN-GN-Industry Life Science R&D Regulatory

Senior Scientist (Bio-Analytical and Bio-Assay)

Director, Country Clinical Operations Management

Site Start Up EUCTR II

Assoc Director - Publishing

LifeScience Regulatory Svs Manager

Sr Clinical Database Programmer

R&D India Site Head

Principal Regulatory Services Advisor

Manager - Submission Management

Senior Director, Head of R&D Global Capability Centers (GCC) - India

Chief Financial Officer (CFO)

Senior Specialist Submission Management

Associate Director, QCP Lead

BC Sector LS-centre for reimagination-Senior Manager

Principal Clinical Data Manager

Director, Quantitative Clinical Pharmacology Lead

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