bengaluru karnataka pharmaceutical quality control Jobs – 148 Open Jobs Today

Regulatory Affairs Expert
Fresenius Medical Care —Bengaluru, Karnataka
- Full-time
- Medicine
- AI
10d
Senior IT Delivery Manager - Life Sciences/Pharmaceuticals
EPAM Systems, Inc. —Bengaluru, Karnataka
- Agile
- IT
- Leadership
- Health insurance
- Paid time off
Product Engineer,R&D
West Pharmaceutical Services —Bengaluru, Karnataka
- Customer service
- Project management
- Bachelor's degree
11d
FS-RISK CONSULTING-TPRM-Campus Staff
EY —Bengaluru, Karnataka
- Microsoft Excel
- Analysis skills
- Communication skills
Automation Tester
Qualitest —Bengaluru, Karnataka
- Full-time
- Computer Science
- AWS
- Project management
Business Intelligence Analyst
Konovo —Bengaluru, Karnataka
- Hybrid work
- Databases
- SQL
- Analysis skills
- Health insurance
Legal & Compliance Counsel
Alexion Pharmaceuticals,Inc. —Bengaluru, Karnataka
- Bachelor's degree
- Communication skills
7d
Review Associate - AP
Lighthouse Document Technologies Inc —Bengaluru, Karnataka
- Weekend availability
- Master's degree
- Bachelor's degree
- Quality control
Quick apply
Scrum Master
Takeda Pharmaceutical —Bengaluru, Karnataka
- Full-time
- Azure
- DevOps
- Engineering
Clinical Research Associate II
Fortrea —Bengaluru, Karnataka
- Full-time
- Patient monitoring
- Customer service
- Computer literacy
Finance Tech - FCPM - Campus
EY —Bengaluru, Karnataka
- Microsoft Excel
- Master's degree
- Analysis skills
Research Associate III
Vantive —Bengaluru, Karnataka
- Data analysis skills
- English
- Research
People Consulting-WFM-Campus
EY —Bengaluru, Karnataka
- Microsoft Excel
- Master's degree
- Analysis skills
Branch Head (Travel Industry)
Trident HRM Services Pvt Ltd —Bengaluru, Karnataka
- ₹20,00,000 - ₹25,00,000 a year
- Full-time
- Management
- Bachelor's degree
- Travel
Quick apply
14d
Non FS Finance - Commerical - Campus
EY —Bengaluru, Karnataka
- Microsoft Excel
- Master's degree
- Analysis skills
FS-RISK CONSULTING-DIGITAL RISK-ITCA-Campus
EY —Bengaluru, Karnataka
- Microsoft Excel
- Analysis skills
- Communication skills
Program Manager
ConcertAI —Bengaluru, Karnataka
- Full-time
- Computer Science
- PMP
- Master's degree
Finance tech - EPM - Campus
EY —Bengaluru, Karnataka
- Microsoft Excel
- Master's degree
- Analysis skills
Partner, RA Data Governance
Astellas —Bengaluru, Karnataka
- Spanish
- Doctoral degree
- English
Supplier Development Manager
Airbus India Private Limited —Bengaluru, Karnataka
- Email
- Project management
- Manufacturing
- Communication skills

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Regulatory Affairs Expert

Fresenius Medical Care -
Bengaluru, Karnataka

Apply Now

Job details

Full-time
10 days ago

Qualifications

Medicine
Diagnostic evaluation
AI

Full job description

General:

Works independently on tasks and projects within the scope of Product Regulatory Affairs, ensuring compliance with applicable regulations and standards.
Establishes and manages priorities effectively to meet deadlines and align with business and regulatory requirements.
Exercises sound judgment makes informed decisions within their area of responsibility and assumes accountability for outcomes.
Provides technical guidance and support to Junior Regulatory Affairs Experts, fostering their development and ensuring high-quality deliverables.

Regulatory Documentation

Preparation, maintenance, review, and approval of global regulatory product documentation, including Global Technical Documentation and Registration Files, ensuring strategic alignment and compliance.
Oversee the development, harmonization, and approval of content for Instructions for Use (IFU), Service Manuals (SM), Installation Guides (IGL), and product labeling to meet global regulatory and market requirements.
Serve as a subject matter expert, providing advanced regulatory guidance and interpretation of compliance standards and associated testing strategies.
Advise and collaborate with cross-functional teams on regulatory considerations in design and development projects, influencing product and process decisions.
Manage and approve change notifications submitted to Notified Bodies and Regulatory Authorities, ensuring timely and accurate communication.
Drive and oversee conformity assessments for new medical devices (nMD), medical devices (MD), and other regulated products, ensuring alignment with risk classifications and applicable standards.
Author and validate expert opinions and risk evaluations to support product compliance documentation.
Conduct the preparation of the technical content for Clinical Evaluation Plans and Reports, ensuring robustness and regulatory adequacy.

Product Registration

Ensure and strategically guide regulatory product availability in global markets in support of the company’s business objectives and commercial strategy.
Maintain oversight of global regulatory requirements and activities, providing expert coordination and direction to regional teams and stakeholders.
Define, align, and communicate regulatory strategies and roadmaps in partnership with cross-functional and regional partners.
Oversee the execution and maintenance of product registrations, renewals, and submissions worldwide, resolving complex regulatory challenges proactively.
Direct the compilation of standardized global registration files (e.g., STED) and lead their adaptation for local submissions.
Approve Free Sale Certificates and declarations for regulatory submissions, ensuring accuracy and compliance.
Lead the registration of medical devices (including trading goods and kits), production sites, and new production lines, ensuring adherence to applicable laws and guidelines.
Provide senior-level support and strategic input for pharmaceutical registrations where medical devices are classified as medicinal products.
Represent Regulatory Affairs in tenders, delivering regulatory documentation and strategic input as needed.

Change Management

Chair or lead participation in design change councils, providing authoritative regulatory direction on change control processes.
Evaluate, approve, and guide the implementation of complex product and process changes from a global regulatory perspective.
Lead global communication and alignment of regulatory changes across regions and stakeholders, ensuring consistency and compliance.
Oversee and validate local assessments of regulatory impacts and drive resolution of feedback and challenges.
Monitor and report on the implementation of changes, maintaining high-level oversight of status, risks, and mitigation plans.
Act as regulatory project leader for significant change initiatives, ensuring timely delivery and compliance.

Support, Creation, and Review

Lead the drafting, review, and approval of Declarations of Conformity and related compliance documentation.
Oversee the creation, maintenance, and governance of Product Center Information and other regulatory data repositories.
Provide senior-level review and decision-making on Additional Information (AI), Supplementary Requests (SR), and other regulatory inquiries.
Guide and approve product-related technical documentation, marketing materials, and other customer-facing content from a regulatory standpoint.
Maintain, review, and enhance the global list of applicable standards, ensuring currency and alignment with evolving regulatory landscapes

Apply Now

Refine Your Search

pharmaceutical quality control jobs in bengaluru karnataka

Regulatory Affairs Expert

Senior IT Delivery Manager - Life Sciences/Pharmaceuticals

Product Engineer,R&D

FS-RISK CONSULTING-TPRM-Campus Staff

Automation Tester

Business Intelligence Analyst

Legal & Compliance Counsel

Review Associate - AP

Scrum Master

Clinical Research Associate II

Finance Tech - FCPM - Campus

Research Associate III

People Consulting-WFM-Campus

Branch Head (Travel Industry)

Non FS Finance - Commerical - Campus

FS-RISK CONSULTING-DIGITAL RISK-ITCA-Campus

Program Manager

Finance tech - EPM - Campus

Partner, RA Data Governance

Supplier Development Manager

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