
Director of Quality Assurance and Regulatory Affairs
3 days ago
Senior Quality Assurance and Regulatory Affairs Leader
We are seeking a highly experienced and visionary professional to lead our Quality Assurance and Regulatory Affairs team in India.
This senior leadership role is responsible for ensuring compliance with medical device regulations and global quality standards, while building and executing a long-term strategy for excellence in Quality Assurance and Regulatory Compliance in India.
- Strategic Leadership & Compliance (30%):
- Develop, implement, and oversee the local Quality Management System (QMS) in alignment with Global Sales QMS and Indian regulatory requirements.
- Provide regulatory and quality leadership to ensure all products meet compliance with Indian laws and global standards.
- Drive the Quality Assurance and Regulatory Compliance strategic plan for India, aligning with business objectives.
- Regulatory & Post-Market Vigilance (30%):
- Ensure all regulatory submissions, registrations, and filings are completed on time and in compliance with national and global requirements.
- Oversee post-market vigilance activities, including complaint handling, incident reporting, and corrective/preventive actions.
- Serve as the primary liaison with regulatory bodies including CDSCO, Ministry of Health & Family Welfare, Bureau of Indian Standards, and certification bodies such as TV SD.
- People & Organizational Leadership (25%):
- Lead, mentor, and develop the Quality Assurance and Regulatory Compliance team, including managers and specialists.
- Foster a culture of accountability, collaboration, and continuous improvement.
- Retain and grow high-potential talent while ensuring team alignment with business goals.
- Product Registration & Market Access (15%):
- Manage timely and compliant product registration processes to support market access.
- Anticipate regulatory changes and proactively develop strategies to ensure compliance readiness.
-
Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000Regulatory Affairs Manager Job DescriptionThe role involves developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management: Preparation, review and submission of regulatory documentation (e.g., dossiers,...
-
Regulatory Affairs Professional
5 days ago
Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 2,20,00,000 - ₹ 2,54,00,000Regulatory Affairs LeaderSr Manager Regulatory Affairs responsible for developing and executing regulatory strategies, compiling and reviewing regulatory submissions, ensuring product compliance, and acting as a key liaison with regulatory agencies.Key Responsibilities:Submission Management:Preparing, reviewing, and submitting regulatory documentation to...
-
Head - Quality & Regulatory Compliance
4 days ago
Mumbai, Maharashtra, India Getinge Full timeJob Overview:We are seeking an experienced and visionary Head of Quality and Regulatory Compliance (QRC) to lead and oversee all aspects of Quality Assurance and Regulatory Affairs in India. This senior leadership role is responsible for ensuring compliance with Medical Devices Rules 2017 and global quality standards, while building and executing a long-term...
-
Regulatory Affairs Specialist
12 hours ago
Mumbai, Maharashtra, India Tek Support Full timeJob DescriptionJob Title: Regulatory Affairs Specialist Med/Pharma (Female)Location: RemotePosition Overview:We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities,...
-
Regulatory Affairs Lead
5 hours ago
Mumbai, Maharashtra, India beBeeChemistry Full time US$ 8,00,000 - US$ 14,00,000Regulatory Affairs Lead PositionWe are seeking an experienced and skilled Regulatory Affairs Sub-Function team leader to oversee product registration submissions, progress reports, supplements, amendments, or periodic experience reports.Key Responsibilities:Supervise a team of professionals in directing product registration submissions, progress reports,...
-
Regulatory Affairs Professional
1 week ago
Mumbai, Maharashtra, India beBeeSpecialist Full time US$ 40,000 - US$ 80,000Regulatory Affairs SpecialistThe role involves the compilation, submission and management of regulatory documentation for assigned projects.Responsibilities include maintaining accurate database records pertaining to products, in line with established systems and processes.Supporting and coordinating regulatory affairs projects, as assigned, including tender...
-
Manager- Regulatory Affairs
2 weeks ago
Mumbai, Maharashtra, India Piramal Enterprises Full timeJob DescriptionJob Description :Business: Piramal Critical CareDepartment: Regulatory AffairsLocation: KurlaTravel: LowJob OverviewThe Manager, Regulatory Affairs is responsible for the portfolio of Piramal Critical Care Products in the USA market. They will be responsible for authoring and reviewing submissions for dissemination to Health Authorities,...
-
Senior Manager Regulatory Affairs
4 weeks ago
Mumbai, Maharashtra, India Laxmi Dental Limited Full timeJob Description Job Title: Sr.Manager RA No of Vacancy: 1 Job Location: Andheri Years of Experience:10 - 20 years Working Days: Monday to Saturday Job Summary: We are seeking a dynamic and experienced Senior Manager – Global Regulatory Affairs to lead regulatory strategy, compliance, and market authorization activities across all regions (including...
-
Regulatory Affairs Specialist
2 days ago
Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 12,00,000 - ₹ 18,00,000Regulatory affairs specialists play a vital role in ensuring compliance with regulatory requirements and facilitating the smooth operation of businesses.This position requires an individual with expertise in regulatory affairs, including experience with eCTD software and e-publishing requirements throughout the project lifecycle. The ideal candidate will...
-
Senior Regulatory Affairs Professional
57 minutes ago
Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 25,00,000Regulatory Affairs SpecialistMain Purpose of Role:The Regulatory Affairs Specialist will be a key contributor to the development and implementation of regulatory strategies for our products.This role requires an individual with comprehensive knowledge in the area of Regulatory Affairs, who can execute highly complex or specialized projects, and adapt...