Head - Regulatory Affairs | Medical Devices | Bangalore

7 hours ago

Bangalore Division, India Michael Page Full time

Drive regulatory strategy with global impact at a leading healthtech innovator Leadership role with strong visibility and growth potential About Our Client This opportunity is with a global MNC recognized for its contributions to the life sciences industry. Job Description Regulatory 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 Applicant Education: 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

  • Head - Regulatory Affairs | Medical Devices | Bangalore

    2 weeks ago

    Bangalore Division, India Michael Page Full time

    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...

  • Regulatory Affairs Specialist

    1 week ago

    bangalore, India Concept Medical Full time

    About Us:Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are expanding our team in the...

  • Senior Regulatory Affairs Trainer(Medical Devices)

    1 week ago

    bangalore, India Tek Support Full time

    Job Title: Senior Trainer – Regulatory Affairs (Medical Devices)Location: RemoteJob Type: Part-TimeJob Summary:We are seeking an experienced Regulatory Affairs Trainer with deep expertise in medical device regulations and compliance to design and deliver advanced training programs for professionals in the medical device industry. The ideal candidate will...

  • Quality & Regulatory Lead- Medical Devices

    7 hours ago

    Bangalore Division, India Michael Page Full time

    Opportunity to lead QA RA for medical implants greenfield project Set up and maintain the Quality Management System in ISO 13485 About Our Client Global medical devices client in the space of orthopedic implants Job Description Regulatory Affairs: Lead interactions with Indian health authorities (CDSCO) for the registration and continued compliance of our...

  • Regulatory Affairs Specialist

    13 hours ago

    bangalore, India NexorTest Technologies Full time

    Location: Bengaluru / Hybrid Experience: 5 - 8 yearsOverall Package: 8 - 10 LPARole Summary:The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working cross-functionally...

  • Regulatory Affairs Specialist

    17 hours ago

    bangalore, India NexorTest Technologies Full time

    Location: Bengaluru / Hybrid  Experience: 5 - 8 years Overall Package: 8 - 10 LPA Role Summary: The Regulatory Affairs senior specialist will be responsible for planning, preparing, and managing regulatory submissions and compliance activities for medical devices under CDSCO (India), EU MDR, and US FDA frameworks. The role involves working...

  • Regulatory Affairs

    7 hours ago

    Konkan Division, India J D HEALTHCARE LIMITED Full time

    Company Overview JD Lifesciences, operating under J D HEALTHCARE LIMITED, i s a fast-growing healthcare company specializing in biomedical equipment and life-saving medical solutions. We are committed to delivering reliable, innovative and quality products to hospitals, clinics and healthcare institutions across the country. Job Overview We are seeking a...

  • Regulatory Affairs Executive

    3 weeks ago

    bangalore, India Halma plc Full time

    About Halma: Halma 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 specialize in market leading technologies that push the...

  • Regulatory Affairs Executive

    3 weeks ago

    Bangalore, India Halma plc Full time

    About Halma: Halma 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 specialize in market leading technologies that push the...

  • Quality & Regulatory Lead- Medical Devices

    5 days ago

    Bangalore Division, India Michael Page Full time

    Opportunity to lead QA RA for medical implants greenfield projectSet up and maintain the Quality Management System in ISO 13485About Our ClientGlobal medical devices client in the space of orthopedic implantsJob DescriptionRegulatory Affairs:Lead interactions with Indian health authorities (CDSCO) for the registration and continued compliance of our implants...