Bengaluru Karnataka Clinical specialist Jobs – 167 Open Jobs Today

Regulatory Affairs Specialist
ZEISS Group —Bengaluru, Karnataka
- Full-time
- Microsoft Office
- Master's degree
- Bachelor's degree
Site Specialist
ICON Plc —Bengaluru, Karnataka
- Full-time
- Analysis skills
- Bachelor's degree
- Communication skills
- Health insurance
duty doctor
Suncoast Hospital —Kalyananagar, Bengaluru, Karnataka
- ₹35,000.14 - ₹74,942.94 a month
- Full-time
- Medicine
- Blood sampling
- Patient monitoring
Quick apply
2d
Manager - Cell & Gene Therapy - Bioscience
Thermo Fisher Scientific —Bengaluru, Karnataka
- Full-time
- Sales
- Master's degree
- Business development
Veeva Vault Quality Testing Specialist
Bayer —Bengaluru, Karnataka
- Computer Science
- Engineering
- English
HR - Talent Acquisition
Dezy —Bengaluru, Karnataka
- Master's degree
- Bachelor's degree
- Human resources
Quick apply
8d
India GCC - Sales Capture Practitioner
Accenture —Bengaluru, Karnataka
- Full-time
- Sales
- ERP systems
- Master's degree
IVF Specialist
PN IVF Access PVt LTD —Bengaluru, Karnataka
- Up to ₹90,000 a year
- Full-time
- Bachelor's degree
- Patient care
- In-person
Quick apply
9d
Business Specialist - Dr Channel
Twin Health —Bengaluru, Karnataka
- Microsoft Excel
- English
- Communication skills
Quick apply
HR Associate
smiles.ai —Bengaluru, Karnataka
- Bachelor's degree
- Human resources
- Computer networking
General Physician
Health Plus Multi Speciality Hospital —Krishnarajapuram, Bengaluru, Karnataka
- ₹30,000 - ₹80,000 a month
- Weekend availability
- Medicine
- Bachelor's degree
- In-person
- Flexible schedule
Quick apply
HR - Talent Acquisition
smiles.ai —Bengaluru, Karnataka
- Master's degree
- Bachelor's degree
- Human resources
8d
Talent Acquisition Manager
Teleradiology Solutions (TRS) —Bengaluru, Karnataka
- Full-time
- Bachelor's degree
- Recruiting
- Business Administration
13d
Software Engineer Architect – AI Agents (Healthcare)
100MS —Bengaluru, Karnataka
- ₹50,00,000 - ₹1,00,00,000 a year
- Hybrid work
- Azure
- Master's degree
- AWS
Quick apply
12d
DMO
Evani hospital —Bengaluru, Karnataka
- ₹45,000 - ₹60,000 a month
- Weekend availability
- Medicine
- ACLS Certification
- Bachelor's degree
Quick apply
Healthcare Marketing
Ovum Hospitals —Kalyan Nagar, Bengaluru, Karnataka
- ₹9,027.73 - ₹43,899.15 a month
- Full-time
- Marketing
- Bachelor's degree
- Travel
- Flexible schedule
Quick apply
PMO Tools and Automation Specialist
Solventum —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Office
PCS Operations Team Lead
Solventum —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
Data Platforms Operations Expert
Astellas —Bengaluru, Karnataka
- Hybrid work
- Microsoft Powerpoint
- Microsoft Excel
- Microsoft Access
- Work from home
9d
India SVG National Sales Manager/SVG Business Head
GE HEALTHCARE —Bengaluru, Karnataka
- Microsoft Powerpoint
- CRM software
- Microsoft Excel

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Regulatory Affairs Specialist

ZEISS Group -
Bengaluru, Karnataka

Apply Now

Job details

Full-time

Qualifications

Microsoft Office
Diagnostic evaluation
.NET
Master's degree
Bachelor's degree
FDA regulations

Full job description

ZEISS in India

ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics.

ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace.

Further information at ZEISS India .

Job purpose

To support the planning, execution, and management of regulatory activities for global medical devices (software and hardware), ensuring compliance with EU MDR, US FDA, and other country-specific regulations. The role focuses on preparing regulatory submissions, monitoring post-market commitments, and collaborating with cross-functional teams to meet program milestones.

Duties and responsibilities

Regulatory Support:

Assist in preparing technical documentation and submissions for Class I, IIa, and IIb medical devices in compliance with EU MDR and US FDA 510(k).
Support country-specific registration processes (e.g., China NMPA and other international markets).
Participate in the evaluation of regulatory impacts for design changes such as ECRs, PSM decisions, and updates to claims matrices.

Coordination and Collaboration:

Collaborate with Product Management, Clinical Affairs, QA, and Program Delivery teams to align regulatory timelines with project objectives.
Represent Regulatory Affairs in team meetings and provide regulatory input to support product development and market approvals.

Submission and Documentation Management:

Prepare and maintain documentation such as STED, GSPR, DoC, CER, and PMS reports.
Assist in monitoring timely country releases across various markets and manage change notifications.

Risk and Post-Market Oversight:

Identify potential regulatory risks and propose mitigation strategies.
Support post-market regulatory activities, including responses to regulatory authorities and tracking post-market surveillance.

Process Improvement:

Contribute to initiatives for process standardization and digitalization in regulatory activities (e.g., Signavio /CARA/Polarian /ADO tools).

Qualifications

Bachelor’s/Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
3–5 years of experience in Regulatory Affairs for medical devices.
Strong working knowledge of EU MDR and US FDA 510(k) requirements.
Exposure to multi-country registrations and clinical evaluation processes like CER and PMS is preferred.
RCC or equivalent certification is a plus.
Familiarity with technical documentation structure is an advantage.
Strong MS Office and documentation skills.

Other Attributes

Strong attention to detail and structured problem-solving skills.
Effective communication and collaboration abilities in global cross-functional teams.
Accountability and ownership of assigned tasks.
Ability to adapt to evolving regulatory landscapes and manage ambiguity effectively
Comfortable working across time zones.

Job purpose

Duties and responsibilities

Regulatory Support:

Assist in preparing technical documentation and submissions for Class I, IIa, and IIb medical devices in compliance with EU MDR and US FDA 510(k).
Support country-specific registration processes (e.g., China NMPA and other international markets).
Participate in the evaluation of regulatory impacts for design changes such as ECRs, PSM decisions, and updates to claims matrices.

Coordination and Collaboration:

Collaborate with Product Management, Clinical Affairs, QA, and Program Delivery teams to align regulatory timelines with project objectives.
Represent Regulatory Affairs in team meetings and provide regulatory input to support product development and market approvals.

Submission and Documentation Management:

Prepare and maintain documentation such as STED, GSPR, DoC, CER, and PMS reports.
Assist in monitoring timely country releases across various markets and manage change notifications.

Risk and Post-Market Oversight:

Identify potential regulatory risks and propose mitigation strategies.
Support post-market regulatory activities, including responses to regulatory authorities and tracking post-market surveillance.

Process Improvement:

Contribute to initiatives for process standardization and digitalization in regulatory activities (e.g., Signavio /CARA/Polarian /ADO tools).

Qualifications

Bachelor’s/Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
3–5 years of experience in Regulatory Affairs for medical devices.
Strong working knowledge of EU MDR and US FDA 510(k) requirements.
Exposure to multi-country registrations and clinical evaluation processes like CER and PMS is preferred.
RCC or equivalent certification is a plus.
Familiarity with technical documentation structure is an advantage.
Strong MS Office and documentation skills.

Other Attributes

Strong attention to detail and structured problem-solving skills.
Effective communication and collaboration abilities in global cross-functional teams.
Accountability and ownership of assigned tasks.
Ability to adapt to evolving regulatory landscapes and manage ambiguity effectively
Comfortable working across time zones.

Your ZEISS Recruiting Team:

Saptarshi Chowdhury

Apply Now

Refine Your Search

clinical specialist jobs in bengaluru karnataka

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duty doctor

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