bengaluru karnataka regulatory affairs manager Jobs – 42 Open Jobs Today

Manager Regulatory Affairs - IN
DeepHealth —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Bachelor's degree
- Travel
- Communication skills
Quick apply
Program Manager, Regulatory Affairs, Maternal Infant Care
GE HEALTHCARE —Bengaluru, Karnataka
- Microsoft Word
- Computer Science
- Word processing
Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs
Cepheid —Bengaluru, Karnataka
- Full-time
- Master's degree
- Bachelor's degree
- Travel
- Paid time off
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
Specialist - Regulatory Affairs - Operations 4A
Genpact India Pvt. Ltd. —Bengaluru, Karnataka
- Full-time
- Hybrid work
- Data analysis skills
- English
- Master's degree
Quick apply
Manager - CMC Regulatory
Elanco —Bengaluru, Karnataka
- Full-time
- Master's degree
- Bachelor's degree
- Travel
Senior Regulatory Affairs
Saraca Solutions —Bengaluru, Karnataka
- Bachelor's degree
- Travel
- Communication skills
Regulatory Submissions Manager
ICON Plc —Bengaluru, Karnataka
- Full-time
- Bachelor's degree
- Health insurance
CMC Manager - CMC NCR - Vx Mature Products
GlaxoSmithKline —Bengaluru, Karnataka
- Full-time
4d
LEAD - GROUP PUBLIC AFFAIRS
Mahindra & Mahindra Ltd —Bengaluru, Karnataka
- Master's degree
- Bachelor's degree
- Agile
Forms Completion Specialist / Regulatory Compliance Specialist
Lee Spring Company India Pvt Ltd —Bengaluru, Karnataka
- ₹5,00,000 - ₹7,00,000 a year
- Full-time
- Computer Science
- Bachelor's degree
- Human resources
- Health insurance
- Paid time off
Quick apply
8d
Expert-Regulatory Submission Management
Merck KGaA —Bengaluru, Karnataka
- Doctoral degree
- Master's degree
- Communication skills
Lead Biostatistician, Global Quality, Regulatory, Clinical Affairs
Cepheid —Bengaluru, Karnataka
- Full-time
- Doctoral degree
- Master's degree
- Machine learning
- Paid time off
Program Manager
ConcertAI —Bengaluru, Karnataka
- Full-time
- Computer Science
- PMP
- Master's degree
Manager - Legal & Compliance
ISKCON Bangalore (Hare Krishna Hill) —Bangalore City, Bengaluru, Karnataka
- ₹40,000 - ₹55,000 a month
- Full-time
- Bachelor's degree
- Organizational skills
- In-person
- Health insurance
Quick apply
Manager — Public Policy
Growth School —Bengaluru, Karnataka
- Full-time
- AI
- Communication skills
Chemical Compliance Project Manager
Thermo Fisher Scientific —Bengaluru, Karnataka
- Full-time
- PMP
- Master's degree
- Analysis skills
Manager I - BPM
UST Global —Bengaluru, Karnataka
1d
Senior Expert Regulatory Labeling
Merck KGaA —Bengaluru, Karnataka
- Microsoft Powerpoint
- Microsoft Outlook
- Doctoral degree
1d
Associate Director - Content Quality Review - Global Content Hub
Lilly —Bengaluru, Karnataka
- Full-time
- Medicine
- Management
- Doctoral degree

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Manager Regulatory Affairs - IN

DeepHealth
Bengaluru, Karnataka

Quick apply

Job details

Full-time

Qualifications

Diagnostic evaluation
Bachelor's degree
Communication skills
FDA regulations

Full job description

Regulatory Affairs Manager

Job purpose

Reporting to the Director of Regulatory Affairs, the Regulatory Affairs Manager is responsible for executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth’s product and product development and regulatory activities to commercialize new digital products, including AI technologies. This position will provide regulatory input on design and development activities to cross-functional teams, to ensure compliance with the relevant regulatory requirements and interactions with regulatory authorities.

Duties and responsibilities

As the Regulatory Affairs Manager, this position will:

Oversee the day-to-day functions of the India based Regulatory Affairs team members.
Contribute to and execute the regulatory strategies for existing, new and modified medical and non-medical devices.
Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical device.
Leads and manages regulatory submissions, including US 510(k)s submissions, and technical files for CE marking, including Regulatory Body interactions.
Mentor and provide guidance to their direct reports and cross-functional product development teams on regulatory requirements, specifically for the US, UK, and EU markets.
Work closely with business partners and regulatory team members to ensure compliance for and support of OUS regulatory submissions and filings.
Monitor and interpret evolving global regulations, standards, and guidance documents to ensure the company’s regulatory compliance, translating them into action steps for the organization.
Assist in SOP development and review in support of "next-gen" product offerings.
Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products
Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.
Ensure compliance with product post marketing requirements.

Please Note: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned, and management retains the right to add or change duties at any time.

Working conditions

This position may be based in India in a typical office setting.

This position will have the ability to work remotely.

Physical requirements

This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.

Qualifications

Qualifications include:

Bachelor’s degree in relevant field (or equivalent experience)
8 - 10 years working in a regulated industry (FDA and Software as a Medical Device preferred).
Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings for Software as Medical Device.
Experience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus.
Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.
Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56.
Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred.
Excellent written and oral communication skills

Quick apply

Refine Your Search

regulatory affairs manager jobs in bengaluru karnataka

Manager Regulatory Affairs - IN

Program Manager, Regulatory Affairs, Maternal Infant Care

Lead Clinical Data Manager, Global Quality, Regulatory, Clinical Affairs

Staff Regulatory Affairs - Bangalore

Specialist - Regulatory Affairs - Operations 4A

Manager - CMC Regulatory

Senior Regulatory Affairs

Regulatory Submissions Manager

CMC Manager - CMC NCR - Vx Mature Products

LEAD - GROUP PUBLIC AFFAIRS

Forms Completion Specialist / Regulatory Compliance Specialist

Expert-Regulatory Submission Management

Lead Biostatistician, Global Quality, Regulatory, Clinical Affairs

Program Manager

Manager - Legal & Compliance

Manager — Public Policy

Chemical Compliance Project Manager

Manager I - BPM

Senior Expert Regulatory Labeling

Associate Director - Content Quality Review - Global Content Hub

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