Job Description

About us


MERIL


DELIVERING WORLD-CLASS HEALTHCARE SOLUTIONS







Founded in 2006, Meril is an India-based, global medical device company that is dedicated to the innovation, design and development of novel, clinically relevant and state-of-the-art devices. Our fundamental aim is to champion the alleviation of human suffering and improve quality of life. To enable this, we are committed to R&D, innovation in manufacturing medical technology, scientific communication, and contemporary distribution avenues.



Meril was born with the aim of improving the quality of human life through innovative and advanced healthcare solutions. As a medical device manufacturer, we exist to improve the inventiveness in healthcare so that people's lives are enriched. We continually seek excellence in providing answers to some of medicine's toughest questions.



Meril manufactures medical solutions in the form of vascular intervention devices, orthopaedic supplements, in-vitro diagnostics, endo-surgery and ENT products. It is our core commitment to ensure the delivery of advance healthcare solutions. Our inclination towards research and development is reflected in our diverse offerings. We ensure that we adhere to the best quality of standards in manufacturing, scientific communication and distribution to deliver path-breaking healthcare products to the world.



We collaborate with physicians and global innovators to identify unmet clinical needs and develop revolutionary therapies. We encourage research and academic collaborations and remain available to interact on exciting opportunities.



Headquartered in India with a manpower of more than 4000, Meril currently conducts business in more than 100 countries. We have 100% subsidiaries in India, USA, Germany, Brazil, Russia, South Africa, Bangladesh and Turkey. We have set up operations in China and Japan too.






• Indian Regulatory Affairs:
• Lead the preparation and submission of medical device registrations to the Central Drugs Standard Control Organization (CDSCO) in accordance with Indian regulations.
• Ensure compliance with ISO 13485 and other relevant applicable standards for quality management systems.
• Lead the preparation and submission of medical device registrations to the Central Drugs Standard Control Organization (CDSCO) in accordance with Indian regulations.
• Ensure compliance with ISO 13485 and other relevant standards for quality management systems.
• CE & UDFDA Certification Process:
• Coordinate and facilitate the certification process for medical devices, including engagement with Notified Bodies and adherence to EU Directives or Regulations & USFDA requirements.
• Manage the creation and maintenance of technical documentation to support CE marking
• Product Classification and Compliance
• Classify medical devices according to Indian and European regulatory requirements.
• Monitor changes in regulations and standards, ensuring continuous compliance
• Labelling and Documentation: Oversee the development and approval of product labelling, ensuring alignment with Indian and EU regulatory requirements.
• Maintain accurate and comprehensive regulatory documentation for both Indian and EU markets
• Communication and Liaison Act as the primary point of contact for regulatory authorities in India and the EU.
• Engage with internal stakeholders to provide regulatory guidance and ensure alignment with compliance requirements
• Post-Market Surveillance Establish and manage post-market surveillance systems to monitor and report adverse events in compliance with Indian and EU regulations.
• Implement corrective actions as needed
• Quality Management System (QMS) Collaborate with quality assurance teams to maintain an effective QMS compliant with ISO 13485 and other applicable standards Training and Education Conduct internal training programs to educate teams on Indian regulatory requirements, CE certification processes, and changes in relevant standards


Requirements

• Master Degree in Life Science, M. Pharma-QA or Regulatory or Bachelor's degree in a relevant field; advanced degree preferred.
• years of experience in regulatory affairs for medical devices, with a focus on Indian regulations and CE certification.
• In-depth knowledge of Indian regulatory requirements and EU medical device directives/regulations.
• Experience with ISO 13485 and quality management systems.
• Strong communication and interpersonal skills.


Benefits


Backbone system for DCGI & CE certification for three-floor products (300 products)

Salary


3 to 5 Lakhs (PA)
Work Experience


4-5 years
Industry


Medical Device
City


Pardi
State/Province


Gujarat
Country


India
Zip/Postal Code


396191