Regulatory Affairs Manager
Location: Pune, India
Employment Type: Full-Time
Department: Regulatory Affairs
Experience Required: 10–15 Years
Work Model: Hybrid (Minimum 3 Days Office Presence per Week)
Position Overview
We are seeking an experienced Regulatory Affairs Manager to lead global regulatory activities and ensure compliance for medical device products throughout their lifecycle. The successful candidate will drive regulatory strategies, oversee product registrations, manage regulatory submissions, and collaborate with cross-functional teams to bring innovative healthcare technologies to market while maintaining global compliance standards.
This role plays a critical part in ensuring patient safety, accelerating regulatory approvals, supporting business growth, and enabling the successful commercialization of medical devices across global markets.
Key Responsibilities
Regulatory Strategy & Compliance
Develop and execute global regulatory strategies for new product development, product modifications, and lifecycle management activities.
Ensure compliance with international regulatory requirements, standards, and guidelines.
Provide regulatory guidance throughout the product development lifecycle.
Evaluate regulatory impact of design changes, manufacturing changes, labeling updates, and product enhancements.
Regulatory Submissions & Product Registration
Lead preparation, review, and submission of regulatory dossiers and registrations for global markets.
Manage regulatory submissions including:
US FDA 510(k) Premarket Notifications
CE Certification and EU MDR Compliance
Health Canada Medical Device License Applications
CDSCO Registrations and Licensing
Global Product Registrations
Coordinate responses to regulatory authority questions and deficiency letters.
Support product approvals, renewals, and post-market regulatory requirements.
Cross-Functional Collaboration
Partner closely with:
Research & Development (R&D)
Engineering
Quality Assurance
Clinical Affairs
Marketing
Product Management
Manufacturing & Supply Chain
Ensure regulatory requirements are integrated into product development and commercialization plans.
Provide regulatory expertise during design reviews, risk assessments, and project planning activities.
Quality & Risk Management
Support and maintain compliance with:
ISO 13485 Quality Management Systems
ISO 14971 Risk Management
FDA 21 CFR Part 820 Quality System Regulation
EU MDR (Regulation (EU) 2017/745)
Medical Device Rules (MDR) 2017 – India
Participate in audits, inspections, and regulatory assessments.
Drive CAPA (Corrective and Preventive Action) activities related to regulatory compliance.
Regulatory Intelligence & Process Improvement
Monitor emerging global regulations, standards, and guidance documents.
Assess regulatory changes and their impact on business operations.
Develop and implement regulatory process improvements.
Establish and monitor key performance indicators (KPIs) for regulatory operations.
Required Qualifications
Education
Bachelor’s Degree in:
Pharmacy
Life Sciences
Biology
Chemistry
Biomedical Engineering
Engineering or related scientific discipline
Preferred Education
Master’s Degree in a relevant field
Regulatory Affairs Certification (RAC) preferred
Required Experience
10–15 years of experience in Regulatory Affairs within the Medical Device industry.
Proven track record of successful global regulatory submissions and approvals.
Experience managing multiple regulatory projects simultaneously in a fast-paced environment.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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China | Quarry Bay |Liaoning :
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Croatia |Zagreb :
Zagreb |Estonia :
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