Head - Regulatory Affairs | Medical Devices | Bangalore
3 days ago
Drive regulatory strategy with global impact at a leading healthtech innovatorLeadership role with strong visibility and growth potentialAbout Our ClientThis opportunity is with a global MNC recognized for its contributions to the life sciences industry.Job DescriptionRegulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals.Leadership and Team Management- Build and lead a high-performing regulatory team, fostering a culture of excellence, innovation, and accountability.Regulatory Submissions and Approvals- Oversee the preparation, submission, and maintenance of regulatory dossiers.Compliance Oversight- Ensure that the equipments meet the required regulatory standards as set by CDSCO.Cross-functional Collaboration- Partner with Govt affairs, Quality, Business Areas, Marketing and Legal team to integrate regulatory requirements.The Successful ApplicantEducation:Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or related fields. Advanced degrees (, MBA, are an advantage. *Experience:Minimum 10-15 years of regulatory experience (preferably in IVD), with at least 5 years in a leadership role.In-depth understanding of India's Medical Devices Rules, 2017, CDSCO guidelines, and applicable standards (, ISO 13485, ISO 14971).Familiarity with global regulations like FDA (21 CFR), EU MDR/IVDR, and other regional requirements for international market access.Proven track record of managing regulatory strategies for medical device company.Exceptional leadership, communication, and negotiation skills.Strategic thinker with a proactive approach to problem-solving.Ability to navigate complex regulatory landscapes while maintaining agility
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(Urgent Search) Head- Regulatory Affairs
3 weeks ago
Bangalore, India Michael Page Full timeAbout Our Client This opportunity is with a global MNC recognized for its contributions to the life sciences industry. Job Description 1. Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals. 2. Leadership and Team Management- Build and lead a high-performing...
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Associate Staff Regulatory Affairs Specialist
2 weeks ago
Bangalore, Karnataka, India BD Full timeSummary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance This position participates on cross-functional teams leads the development of global regulatory strategies authors regulatory submissions leads interactions with regulatory agencies notified bodies reviews design...
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Senior Regulatory Affairs Trainer
1 week ago
bangalore, India Tek Support Full timeJob Title: Regulatory AffairsLocation: RemoteJob type: Part-timeJob Summary:We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance, submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible for designing and...
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Senior Regulatory Affairs Trainer
7 days ago
bangalore, India Tek Support Full timeJob Title: Regulatory Affairs Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance , submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible...
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Senior Regulatory Affairs Trainer
6 days ago
bangalore, India Tek Support Full timeJob Title: Regulatory Affairs Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance , submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be responsible for...
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Lead Specialist, Regulatory Affairs
3 weeks ago
Bangalore, Karnataka, India GE Healthcare Full timeSummary Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market Be part of a dynamic environment where your...
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Regulatory Compliance Executive
4 days ago
Bangalore, India Halma plc Full timeHalma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of...
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Product Security
1 week ago
Bangalore Division, India Saaki Argus & Averil Consulting Full timeAbout the Client: Our client is a leading Engineering & R&D company, having presence globally Job Role: Product Security - Practice Head Location : Bangalore, Pune (Work from Office) Roles & Responsibilities: Understand client pain points and provide product security solutions for embedded products, preferably in medical device,...
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Product Security
1 week ago
Bangalore Division, India Saaki Argus & Averil Consulting Full timeAbout the Client: Our client is a leading Engineering & R&D company, having presence globally Job Role: Product Security - Practice Head Location : Bangalore, Pune (Work from Office) Roles & Responsibilities: Understand client pain points and provide product security solutions for embedded products, preferably in medical device, automotive,...
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Bangalore Division, India Michael Page Full timeResponsible for launching and leading new greenfield project-med devicesWorking closely with Quality and Regulatory for smooth opsAbout Our ClientLeading International MNC looking to set up manufacturing their first plant in Bengaluru within orthopedic implantsJob DescriptionOversee the final setup and launch of a new production facility, including CMC...
