Asst. Manager

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Job Information

• Date Opened 02/26/2026
• Job Type Full time
• Work Experience 5+ years
• Industry Medical Device
• City vapi
• State/Province Gujarat
• Country India
• Zip/Postal Code 396191
  
  

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.

Job Description

Job Summary:

The Product Registration Specialist for Global Markets is responsible for overseeing and managing the regulatory submission and product registration process for medical devices in non-EU and non-US regions. This includes countries such as Canada, China, Japan, Brazil, India, Australia, Russia, South Korea, and more. The role involves preparing and submitting the necessary documentation to regulatory agencies, ensuring compliance with local regulations, and facilitating timely market access.

Key Responsibilities

• Regulatory Strategy & Compliance:
• Develop and implement regulatory strategies tailored to specific global markets (e.g., Health Canada, ANVISA in Brazil, TGA in Australia, SFDA in Saudi Arabia, PMDA in Japan, and CFDA in China).
• Stay updated with each region's specific medical device registration requirements, guidelines, and regulatory frameworks, including their unique classifications and submission types.
• Coordinate and guide product compliance with international standards, such as ISO 13485, GHTF (Global Harmonization Task Force), and IMDRF (International Medical Device Regulators Forum).
• Submission & Documentation:
• Prepare, compile, and submit documentation for product registrations, renewals, and modifications for countries like Canada, China, Brazil, Japan, India, Australia, and others.
• Ensure accurate translation and localization of documents as required for regulatory submissions in different markets.
• Work with local consultants, distributors, or regulatory partners to facilitate registration in specific countries.
• Liaison with Global Regulatory Authorities:
• Act as the primary point of contact with regulatory authorities in key regions such as ANVISA (Brazil), CFDA (China), PMDA (Japan), Health Canada, CDSCO (India), and TGA (Australia).
• Respond to regulatory authority questions, audits, and requests for additional information in a timely and effective manner.
• Maintain relationships with international regulatory bodies, consultants, and distributors to ensure smooth communication and regulatory pathways.
• Compliance Monitoring & Market Surveillance:
• Monitor ongoing regulatory changes and emerging requirements in non-EU and non-US markets.
• Ensure the company's products comply with country-specific post-market surveillance, vigilance, and adverse event reporting requirements.
• Support regulatory audits and inspections by foreign regulatory agencies and notified bodies.
• Cross-Functional Collaboration:
• Work closely with internal teams (e.g., R&D, Quality Assurance, Manufacturing, Legal) to collect and review the necessary technical documents, clinical trial data, product specifications, and test reports for regulatory submissions.
• Assist marketing and commercial teams by providing guidance on compliant labeling, advertising, and packaging material for each region.
• Product Modifications & Renewals:
• Manage the regulatory submissions for product modifications and changes (e.g., design updates, manufacturing changes) across different global markets.
• Ensure timely renewal of product registrations and licenses to prevent market disruptions.
• Regulatory Intelligence & Risk Management:
• Conduct regulatory intelligence and provide guidance on new regulatory trends, policies, and challenges in global markets.
• Assist in identifying regulatory risks and opportunities in new markets for product expansion.
  

Please Fill Following Form

https://forms.zohopublic.in/merillifesciencespvtltd688/form/AMRegistrationAffairsSpecialistGlobalMarketsMerilG/formperma/HHLiDseURkfgA5so7b48CnlTgKnNQUgHLAdtLwj4XaU

Requirements

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
• 7-8 years of experience in product registration for medical devices, with a focus on global markets (excluding US FDA and CE markets).
• Familiarity with key regulatory frameworks and authorities in international markets like Health Canada, ANVISA (Brazil), CFDA (China), PMDA (Japan), CDSCO (India), and others.
• Strong knowledge of ISO 13485, GHTF/IMDRF guidelines, and other international medical device standards.
• Excellent project management, communication, and organizational skills.
• Experience working with regional consultants and third-party representatives for regulatory submissions.
• Regulatory Affairs Certification (RAC) for international markets is a plus.
  
  

Benefits

• To Registered Meril Group of products to non EU & non US Countries.
• Total Products more than 300
• Total Tentative Countries 40 Plus
  
  

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