Asst. Manager

 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:

1. 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).
  
2. 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.
  
3. 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.
  
4. 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.
  
5. 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.
  
6. 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.
  
7. 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.
  

Requirements

Benefits

·         To Registered Meril Group of products to non EU & non US
Countries. 

·         Total Products more than 300 

·         Total Tentative Countries 40 Plus